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African Consultants for industries such as healthcare, pharmaceutical, medical product, biotechnology, life science, agriculture and clinical trials industries such as Egypt, Kenya, Morroco, South Africa, Zimbabwe, etc.

 

Global Regulatory .com 's Regulatory Consulting Network
25 Most Recent Registered Regulatory Consultants and Consulting Firms

 
25 Most Recent Registered Regulatory Consulting Firms
EuTech Scientific Services, Inc - FDA GMP TESTING, NUTRACEUTICALS TESTING, PHARMACEUTICAL TESTING, MEDICAL DEVICE TESTING, COSMETICS TESTING, LAB CONSUMABLE TESTING, EXTRACTABLE AND LEACHABLE TESTING, ANALYTICAL CHEMISTRY TESTING, CUSTOM SYNTHESIS / CONTRACT MANUFACTURING, LITIGATION SUPPORT EuTech Scientific Services, Inc - EuTech Scientific Services is a Contract Research Company focusing on the development of new analytical methods and the utilization of existing methods for the pharmaceutical, medical device, and nutr
Particle Technology Labs - Particle Size Distribution, Particle Size and Shape / Image Analysis, BET Specific Surface Area, Pore Size Distribution / Porosity, True Density / Bulk Density / Tap Density, Powder Flowability / Powder Rheology, Thermal Analysis / TGA / DSC, PHYSICAL MEASUREMENTS, Powder Flowability Study, MICROSCOPY SERVICES, Image Analysis, Malvern Morphologi G3S Automated Image Analysis System Image-Pro PLUS Clemex Distribution analysis by size/shape, SURFACE AREA & PORE SIZE ANALYSES, B.E.T. Specific Surface Area (Nitrogen Gas Physisorption) Micromeritics Flowsorb II 2300 (Dynamic Flow Technique) Micromeritics TriStar 3000 , PARTICLE SIZE DISTRIBUTION ANALYSES, LASER Diffraction Malvern Mastersizer S & 2000 - Wet & Dry Dispersion Modules, Method Development, Method Validation, Method Transfer Particle Technology Labs - Particle Technology Labs is the leading service laboratory for particle characterization testing in the United States. Located in suburban Chicago, PTL is an independent contract lab that prides itsel
The Horizon Phoenix Group LLC - The Horizon Phoenix Group LLC - HORIZON PHOENIX is a partnership comprised of thirty-seven professionals who combined have more than 450 years experience in product testing, regulatory processes, quality management systems and audit
EUROFINS USA - Food Testing, Feed Testing, Petfood Testing, Microbiology Testing, Dietary Supplement Testing, Agricultural Testing, Pharmaceutical Testing, Amino Acids Analysis, Fatty Acids Analysis, GMO Testing , Inorganic assays, Lipid and Oil Testing, Tests for Meat Species identification & contamination, Microbiology Testing, Mycotoxins Analysis,Tests For Sugar And Starch, Vitamins Testing,Shelf Life Studies, Spoilage Investigations in Canned Foods, FDA Detention Related Testing - Salmonella, Listeria monocytogenes, etc., Challenge Studies, Environmental Monitoring Sampling Programs, include: Aerobic Plate Count Salmonella Yeast Campylobacter jejuni/coli/lari Mold Listeria monocytogenes Total Coliforms and E. coli Listeria species Anaerobic Plate Counts E. coli O157:H7 Mesophillic and Thermophillic Sporeformers Staphylococcus aureus Psychrophilic Plate Counts Bacillus cereus Lactic Acid Bacteria Shigella Alicyclobacillus Vibrio cholera/parahaemolyticus/vulnificus Enterobacter sakazakii (Cronobacter) Clostridium perfringens, Botanical and Supplement Testing Chondroitin Sulfate Testing (USP) Flaxseed Lignan Testing Free Fatty Acids in Saw Palmetto Rebaudioside A Testing (USP-FCC) Weight Management and Thermogenic Ingredients Steviol Glycosides Testing (JECFA) Joint Health Supplement Testing Chondroitin Sulfate Testing (AOAC) Chondroitin Testing Package, Identification of Unknowns Characterization of Mixtures Analysis of Competitive Products Product Quality Control Raw Material ID and Purity Noncompendial Methods Pre-clinical Study Support Analytical Support for Stability Studies EUROFINS USA - Eurofins US is a commercial laboratory network with several locations throughout the United States. Our scientific staff has many years of experience with a broad range of laboratory methods from wet
OrthoKinetic Technologies, LLC - A2LA accredited medical device testing facility provides the following services: standardized mechanical tests per American Society for Testing and Materials (ASTM) and International Organization for Standardization (ISO) standards for multiple types of devices and allograft tissue. Additional services involve the assessment of implant strength, durability, wear simulation and particulate analyses, fatigue resistance, resistance to corrosion multiaxis strength testing, low and high cycle fatigue, cyclic stress and strain, burst and rupture, cyclic rupture, creep, elongation, bending, crack propagation, stress relaxation, suture and tissue retention, fracture toughness, coating integrity, surgical tooling and delivery system evaluation, and failure analyses, computer modeling (FEA) for implant and tissue models, tissue biomechanics, validation of smart technologies (micro and nanotechnologies) evaluation of biomaterials, comprehensive evaluation of materials and biomaterials, clinical evaluation of medical devices, medical technology assessment, safety and performance analyses, forensic engineering, explant analyses of implants and tissue, and failure analyses. Therapeutic Areas - Orthopedics, Neurosurgical, Dental, Wound care, Gynecological, Biologics, Pain management, Rehabilitative medicine, Urological, Biomaterials, Biomechanics. consumer products, toys, sports equipment, textiles. OrthoKinetic Technologies, LLC - OrthoKinetic Technologies, LLC (OKT) is a regulatory and pre-clinical testing and advisory consulting firm. It provides regulatory guidance, assists with regulatory submissions, serves as a liason to
Eurofins Medinet inc - Large Volume stability Metal Analysis Identification of Microorganisms Sterility Testing Proteines Bio Assays Pyrogenes,Hormones,Calcitonine Leachables/extractables - Nitrosammines Medical Devices Method transfer Method validation Method development Sampling Biochemistry Techniques Molecular & Cell Biology Techniques Virology Techniques Microbiology Techniques Pharmaceutical Techniques Innovative Staffing Solutions Eurofins Medinet inc - Eurofins is a first-class Contract Research Organization (CRO), working with pharmaceutical, chemical, medical device, biotechnology and cosmetic clients. We provide an industry-leading network of exp
Pacific Biolabs - MEDICAL DEVICE SERVICES <ul> <li>Biocompatibility</li> <li>Sterilization Validations</li> <li>Sterility Testing</li> <li>Microbiology</li> <li>Endotoxin Testing</li> </ul> PHARM/BIOPHARM SERVICES <ul> <li>In Vivo Toxicology</li> <li>Cytotoxicity</li> <li>Radiolabeled ADME, PK</li> <li>Stability/Shelf-life Testing</li> <li>Bioassays</li> <li>Environmental Monitoring</li> <li>Pyrogen Testing</li> <li>USP Water Testing</li> <li>Microbiology</li> <li>Compendial Assays</li> </ul> OTHER TESTING SERVICES: Disinfectants Tests, ASTM/AATCC/AOAC Microbiology, Microbial Time Kill Studies, Minimum Inhibitory Concentration (MIC), DOT/IATA, EPA, FHSA Toxicology Agrichemical/EPA, Specialty Chemicals Pacific Biolabs - Pacific BioLabs is a contract research organization (CRO) offering testing and research support services to its clients in the medical device, pharm/biopharm, and other industries. Specializing in the
Southeast Testing & Engineering - ISTA Tests, LTL Rule 180, ASTM 4169 Non-Bulk Hazmat Package Testing Compression / Tensile Testing (Constant Load / Variable Speed) Corrugated Analyses (Mullen, ECT, Basis Weight, etc.) Quality Assurance Testing, Package Improvement Random and Vertical Linear Vibration Sine Sweep and Resonance Search Shock Measurement and Recording Other mechanical / paper tests (Internal Pressure, Cobb Size) Hazmat Training for Corporate Hazmat Compliance Consulting on Hazmat Topics, Exemptions & Approvals Southeast Testing & Engineering - South East Testing and Engineering (SETE) is the leading independent third party laboratory specializing in Hazmat and ISTA Package testing in Georgia. We are certified and sanctioned by DOT and ISTA
Microbiology & Quality Associates, Inc. -  Environmental Monitoring  Microbiology testing  Cleaning validation support  Biotech small scale cell culture services  Validation support  Training center  Consulting Microbiology & Quality Associates, Inc. - Microbiology & Quality Associates, Inc., located in the San Francisco Bay Area, is a service organization providing a variety of services to life sciences companies. Our services include:biotech cell
FABEL Consulting - * Regulatory Affairs * Regulatory compliance (risk-based approach) * Quality systems development * QA audits (CAPA focused) * Full GMP compliance programs * FDA pre-approval inspections * FDA problem resolutions - 483s, warning letters * Due diligence (Third-Party and Technology) * Drug development * Competitor consumer product analysis * Formulation design and optimization * Poorly soluble compound and bio-enhancement * Full product lifecycle management from Discovery, Development, Marketing and Supply o Contract Research / Manufacturing Organizations (CROs/CMOs) o Technology transfer o Manufacturing scale up and troubleshooting o Product and process validation o Analytical method development and validation o Stability o Technical writing * Cosmetics, chemicals, foods and nutrition FABEL Consulting - As your third-party service partner in R&D development and regulatory affairs services, we will use a seamless process to support and enhance your operations with achievement of best outcomes each tim
Pharmaceutical Laboratories and Consultants Inc. - Pharmaceutical Testing, Microbiology Testing ♣Microbial Limits <USP61,62> ♣Spore counts ♣AMET  USP <51> ♣Antibiotic testing ♣Stability ♣Disinfectant efficacy testing ♣Use dilution testing Chemistry ♣HPLC Sunscreens Homosalate Octylmethoxycinnamate Avobenzone Benzophenone-3 Analgesics Preservatives Methylparaben Propylparaben Kathon Phenoxyethanol ♣GC Menthol Camphor Alcohols ♣Wet chemistry ♣Stability Validation Services ♣Process Equipment Qualification ♣Utility Systems Qualification ♣Process Validation ♣Test Method validation ♣Analytical Method Development ♣Facility (Clean Room) Validation Quality Assurance Systems ♣Policies and Procedures ♣Master Batch Records ♣Employee Training ♣cGMP Documentation ♣QC/QA Audits Design and Engineering ♣cGMP Design Reviews ♣Engineering Documentation System ♣Calibration Programs ♣Change Control Management Strategic Planning ♣Quality Assurance Master Plans ♣Documentation Programs ♣Milestone Development ♣Management Coaching Other Services ♣Environmental Monitoring Site mapping Establishment of frequencies Microbial (active air) Particulate ♣Raw material/ Manufacturer analysis Pharmaceutical Laboratories and Consultants Inc. - We are more than a testing laboratory.  Our staff has direct industrial experience which allows us to create a unique partnership that contributes to your business's bottom line. Simply put, that is t
Cerebrasol Ltd. - Slice Electrophysiology: -Blind or infra-red visualised patch clamp recordings from brain and spinal cord slices -Extracellular recordings, including measurement of long-term potentiation in hippocampal slices using field potential recordings Ion Channel Pharmacology: -Concentration-dependence -Mechanism of action o State-dependence o Kinetics of modulation o Site of compound interaction o Single channel analysis Specialised Electrophysiology: Central: -Single/multi-unit and field potential recordings -Recordings from all characterised brain regions and nuclei -Recordings from the spinal cord (e.g. dorsal horn neurons) and dorsal roots Peripheral: -Recordings from peripheral nerve (whole nerve/single fibres) -Recordings from peripheral ganglia (single/multi-unit) -Recordings from whole organs/muscle groups as ECG/EMG/EEG Cerebrasol Ltd. - CerebraSol Ltd is a contract research organisation (CRO) which was established to provide high quality highly specialised translational neuroscience research services to the biopharmaceutical industry
Neurosolutions Ltd - Ion Channel Pharmacology Slice electrophysiology Specialised Electrophysiology hERG Screening Neurosolutions Ltd - NeuroSolutions Ltd. was established in 2001 to provide clients with highly specialised contract electrophysiological research. The company provides a flexible, highly skilled service with fast turnaro
Blirt S.A. - -Proteins -Analytics -Chemical synthesis -DNA Gdańsk -Genes -Production Strains -Production of Proteins -Protein Purification -Protein Formulation -Bioanalysis -Synthesis -Research and Development Blirt S.A. - BLIRT (BioLab Innovative Research Technologies) is a biotechnological company established in 2008 and based in the Gdansk Science and Technology Park. BLIRT operates within a unique hybrid business mo
Ameplex Ltd - PCR related services: Standard PCR Real time PCR DNA labelling and modification DNA mutagenesis DNA preparation and clean up DNA sequencing Cloning: Cloning gene of interest Site specific mutagenesis Insertion/deletion Gene expression: Microarray Tissue specific expression miRNA profile Genetics: Citogenetics Single Nucleotide Polymorphism (SNP) Copy Number Variation (CNV) Copy Number Polymorphism (CNP) Recombinant proteins: Expression Purification Concentration Proteomics: Western blots In situ molecule detection Protein-protein interaction and qualification ELISA Bioinformatics: Primer and probe design Sequence assembly and protection Data processing and evaluation Ameplex Ltd - Ameplex Ltd was founded by a team of scientists from the Semmelweis University (Budapest) and University of Debrecen, Medical and Health Science Center (Debrecen) in 2008. 15+ years of academic know h
Smithers Pharma Services, LLC - Pre-clinical and clinical drug formulation development services GLP and cGMP Analytical Chemistry Services - Custom research, formulation and stability support Method development Method validation Method transfer/verification Detection and identification of impurities/impurity profiling Extractable/leachables Assay/content uniformity Stability indicating assay method development Lot and batch release testing Dissolution testing Analysis of chiral compounds Raw material testing Placebo and excipient testing Physical-chemical properties Customized analytical testing Project management and consulting Preclinical and Clinical Bioanalytical Services GLP and non-GLP services Customized LC/MS/MS method development for biological fluids, tissues and explants devices, with strategies to ensure method robustness Stage-specific LC/MS/MS validation in accordance with FDA and EMA guidelines and current industry best practices Continually expanding list of validated methods for non-proprietary compounds Sample analysis for clinical and non-clinical studies Biomarker services In vitro and in vivo metabolism services, including metabolite identification Consulting, training, and troubleshooting services Stability Storage & Testing Support Long-term stability Accelerated stability Intermediate stability Semi-permeable stability containers Refrigerated stability Freeze-thaw cycling Photostability - Option 1 Smithers Pharma Services, LLC - Smithers Pharma Services comprises top experts in the pharmaceutical field, and is a member of The Smithers Group, an independent global leader in delivering trusted solutions by integrating science,
Smithers Rapra - Services: Physical-Mechanical Testing of Products Mechanical Rubber Goods, Belts, & Plastic Products Physical-Mechanical Chemical-Analytical Environmental-Fluid conditioning Hose Pressure Vibration Temperature & Humidity Conditioning 3-A Sanitary Standards Testing Vehicle On Road Durability Winter Testing Spin-up Traction and Braking Split Coefficient Courses Custom Surfaces Secured Site Rentals Tires Tire Valves Standard Lab Testing Force & Moment Rolling Resistance Indoor Tread Wear Laser Profilometry Characterization for Modeling Snow & Ice Traction Laboratory Tire Analysis Wheel Competitive Analysis Medical Devices Physical-Mechanical Chemical-Analytical Fittings/Fasteners O-rings Physical-Mechanical Testing of Materials Custom Mixing, milling, & molding Unvulcanized Rubber Properties in Tension & Compression at Various Temperatures Flex & Fatigue Abrasion Resistance Cold Temperature Properties Dynamic Mechanical Analysis Environmental conditioning & exposure Adhesion Hardness & Density Coefficient of Friction Cut & Chip Resistance Additional Plastics Testing Reference Materials Chemical-Analytical Chemical analysis of rubber & plastics Identification of rubber & plastic materials Complete chemical analysis Contaminate identification 3-A Sanitary Testing Standards Leachables & Extractables Polymer molecular weight characterization Conventional GPC analysis Triple detection and GPC viscosity High temperature GPC Microscopy Pharmaceutical Analysis Technology Consulting Product Consulting Finite Element Analysis Feasibility Studies Equipment, product & material specifications Patent Investigation Failure Analysis & Process Trouble Shooting Material Consulting Material Selection Rubber Compound Development Evaluating Recycled Materials Formula Reconstruction Environmental Stress Analysis Chemical Analysis of Polymers & Raw Materials Contaminate Identification Supplier Benchmarking REACH Legislation Processing & Development Custom Mixing & Molding Plastic Processing Rubber Processing Specialist Manufacturing Material Development Process Selection Rheology Information Services Smithers Rapra - It has been said that nothing is more essential to leadership than knowing how and where to get information, then being able to put it to good use. Since 1925, the hallmarks of our firm have been accu
Jordi Labs, LLC - Contract Analytical Services, Materials Testing, Analytical Chemistry Testing, Bench Chemistry, Elemental Analysis, Gel Permeation Chromatography (GPC), Liquid Chromatography, Mass Spectroscopy, Microscopy, Particle Analysis, Physical Testing, Preparative Purifications, Spectroscopy, Thermal Analysis, Viscosity, Desorption Gas Chromatography Mass Spectroscopy (DMS), Gas Chromatography Mass Spectroscopy (GCMS), Head Space Gas Chromatography Mass Spectroscopy (Headspace GCMS), Liquid Chromatography Mass Spectroscopy (LCMS), Pyrolysis Mass Spectroscopy (PYMS), Quadrupole Time of Flight - Liquid Chromatography Mass Spectroscopy (QTOF-LCMS), Method Development, High Performance Liquid Chromatography for Additives Quantitation (HPLC-A), High Performance Liquid Chromatography (HPLC) - Qualitative with/without Fraction Collection, Reverse Phase Chromatography (RP) Method Development, Normal Phase Chromatography (NP) Method Development, Ion Exchange Chromatography (IEC) Method Development, ESCA Analysis, EDAX or XRD Analysis,Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Neutron Activation Analysis (NAA), Proton Induced X-ray Emission (PIXE) Jordi Labs, LLC - Jordi Labs was founded in 1980 to provide the highest quality analytical services, polymer based HPLC columns and packing media in the industry. As a family company, we take pride in the production of
Del Corno & associati s.a.s - -CTA applications for every clinical trial phase (phase I- IV)in Italy -Time and cost planning for regulatory activities: regulatory support to the most convenient regulatory approach -Regulatory support to developing companies -Redaction of EU CTD dossiers, including preparation of NeeS and eCTD dossiers -Lifecycle management of medicinal products: updates, variations and renewals -National and European registration and maintanance procedures (MRP and Centralized) -Due diligences activities: licensing support -Pharmacovigilance -Regulatory/Pharmacovigilance Training -Medical devices/Cosmetics Support Del Corno & associati s.a.s - Del Corno & associati is a regulatory consultancy providing services to the pharmaceutical industry, aimed at developing and obtaining the appropriate authorizations to market medical products, medica
Institute of Personal Care Science - Course Overviews, Diploma of Personal Care Formulation, Diploma of Personal Care Development & Promotion Specialist Electives, Short Courses Institute of Personal Care Science - The cosmetics and personal care industry is one of the fastest emerging industries of today - innovation and education is what it takes to stay at the forefront with every cosmetic product and persona
Clinical Laboratory Sales Training, LLC - Sales Training Topics: how to differentiate your lab benefits of coaching building credibility improving sales rep performance compliance personalizing your selling strategy what to look for when hiring a representative managing your sales staff Sample Tests/Disease Presentations: Affirm VP III® Alpha feto protein Amenorrhea evaluation ANCA (MPO/PR3) B-type natriuetic peptide Bartonella antibodies bcr/abl fusion transcripts (qual/qnt) Bladder Cancer Bone biomarkers (CTx, NTx, P1NP, etc) CA 125 CA 15-3 CA 19-9 CA 27.29 Clostridium difficile Celiac disease Cerebral spinal fluid testing Chlamydia (CT) Complete blood count Congenital adrenal hyperplasia CRP, highly sensitive CYFRA 21-1 CYP450 2D6 & 2C19 CYP2C19 - Plavix® CYP2C9 *2*3 Cystic fibrosis Des-gamma-carboxy-Prothrombin DPYD*2A mutation analysis Epidermal growth factor receptor mutation Factor V Leiden mutation Fecal occult blood Ferritin Fetal fibronectin Fetal lung maturity tests FIP1L1-PDGFRα gene fusion (4q12 Rearrangement) First trimester maternal screening Fragile X syndrome FreeliteT Free Light Chain Test FLT3 mutation analysis Genetic abnormalities Gonorrhoeae (NG) GlycoMarkT Gram stain Grave's disease Group A Strep by PCR Group B strep by PCR H. pylori Hashimoto's disease Hemoglobin A1c Hepatitis B Hepatitis C Hereditary hemochromatosis Herpes simplex virus HLA-B*5701 HPV JAK2 V617F mutation Kidney Stone Metabolic profile KRAS mutation Leukemias & lymphomas Lipid testing Liver function profile Lp-PLA2 Lyme disease Methodologies used by a hematopathologist Myasthenia gravis Neural tube defects Non-Gyn Pathology Pap Smear Parathyroid hormone Pathology - definition of terms Prostate specific antigen Prothrombin factor II mutation Quad screen QuantiFERON-TB Gold Test® Sjogren's syndrome Syphilis Systemic lupus erythematosis Tandem mass spectrometry Tay-Sachs disease Thiopurine Methyltransferase (TPMT) Toxicology Thyroid disease Thyroid stimulating hormone UGTA1A molecular assay Upper respiratory disease (allergy testing) Venous thrombosis Vitamin D VKORC1 ZAP-70 Clinical Laboratory Sales Training, LLC - Clinical Laboratory Sales Training helps laboratories grow their business by providing sales methodologies and background test information to individuals who call on physician offices and hospitals. W
Pharmathen Pharmaceuticals - Licensing, Pharmaceutical Development, Pharmathen's global activities are co-ordinated by the departments of Business Development and Planning & Logistics. The aim is to grow Pharmathen's international business and reputation within the industry and to make the company Europe's leading developer of generic products by the end of 2013, a task we are currently well on track to achieve. The global activities of Pharmathen are divided into two distinct parts, those countries where their economies and pharmaceutical markets are well developed, and elsewhere where the economies and markets are in a developing stage. In the developing markets we operate through agents and distributors, through whom we sell Pharmathen's products on the local market. We are currently active in 45 countries and we are currently selling more than 40 products, both from our long established range of products and our new development projects. These operations and the variety of products available continuously increase. Pharmathen Pharmaceuticals - With a long history of development and manufacturing of generic products, Pharmathen has emerged as one of the largest generic development companies in Europe with a development pipeline of ten generi
Clinical Research Quality Assurance - Quality Systems, GLP, GCP, Clinical Trials, Audits, Consulting, Quality Assurance, Total Quality Management, Training, SOP Development, Pharmaceutical, Biotechnology, Phase I Clinical Trials, Phase II Clinical Trials, Phase III Clinical Trials, Phase IV Clinical Trials Clinical Research Quality Assurance - CRQA is an independent auditing and consulting firm based in Delhi, INDIA. We are an organization comprised of people specializing in Total Quality Management. We provide full range of GCP, GLP, quali
Southern Research - Preclinical Drug Development, Basic Research & Target Identification, Lead Discovery and Optimization, Clinical Trial Support, Biochemistry & Molecular Biology, Medicinal Chemistry, Advanced Materials and Structures, Stablized Gimbal Systems, Systems Engineering and Integration, Airborne Sensor Integration, Blast Engineering and Explosion Mitigation, Environment & Energy, Air Pollution Control, Catalyst and Membrane Development, Clean Vehicles and Fuels, Combustion Technologies, Greenhouse Gas Mitigation, Renewable and Bioenergy Systems, Syngas Cleaning, Thermochemical Conversion, Water and Wastewater Research and Remediation Southern Research - Southern Research is a self-sustaining contract research organization and an incorporated affiliate of The University of Alabama at Birmingham (UAB). We are brought together because of a shared belief
Brixham Environmental Laboratory - Astra Zeneca - We offer laboratory based assessment of the environmental effects, ecotoxicity and environmental fate of new and existing substances. Our services can be easily classified according to the following industrial sectors: Industrial Chemicals (REACh) Brixham Environmental Laboratory is part of a global testing alliance and as such can offer a complete REACh service. We can provide both the Brixham Environmental Laboratory - Astra Zeneca - Brixham Environmental laboratory has, for over 60 years, provided a specialised service to the chemical industry. We offer innovative approaches together with intelligent laboratory- based testing req
If you have any questions, please do not hesitate to contact us Toll-Free at 1-877-353-0451 or email us

International Regulatory News

UKAS Assessment Programme for Accreditation for Certification of Green Deal Advisors and Installers
2011-12-12 00:00:00
The deadline for applications to participate in the UKAS programme for the accreditation of certification bodies to certify Green Deal Advisors and Installers expired on 30 September 2011. UKAS received 33 applications from organisations who wish to ... 

Trident catheter valve - Model Number: 380851
2011-12-12 00:00:00
The Therapeutic Goods Administration (TGA) advises that certain lots of the Trident Catheter Valve (Australian Register of Therapeutic Goods (ARTG) number 107139) are being recalled. The Trident Catheter Valve is used for connecting a urinary cath... 

TGA reforms: a blueprint for TGA's future
2011-12-08 00:00:00
Government to improve regulation of therapeutic goods media release, The Hon Catherine King MP 8 December 2011 The Australian Government has released its response to several major reviews of therapeutic goods regulation that have been undert... 

Respirtek ISO 17025 Business Management Improvements
2011-11-22 00:00:00
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients wel... 

Respirtek, Inc. ISO 17025 Accreditation Announcement
2011-11-22 00:00:00
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients wel... 

UKAS Accreditation for Inspection of Fairground and Amusement Park Devices - Pilot Project Update
2011-11-11 00:00:00
The first pilot assessment by UKAS of an inspection body involved in inspection of fairground and amusement park devices is now under way. A pre- assessment of Jacobs Engineering (UK) Ltd, Ashton Lane, Manchester was conducted by UKAS recently, wher... 

ACCREDITATION MATTERS ISSUE 8 NOW AVAILABLE
2011-11-08 00:00:00
A new edition of Accreditation Matters, UKAS' newsletter for the public sector, has been released. Issue 8 gives information about the appointment of UKAS as the accreditation body for the Green Deal, the Government's flagship programme for improving... 

Nova now provides Sterility and Endotoxin Testing for the Radiopharmaceutical Industry
2011-11-01 00:00:00
Radiopharmaceutical sterility testing is required during the sterilization validation process as well as for routine product release testing. USP <71> sterility testing is an official test to determine sterility of a product. Nova's understanding of ... 

FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation
2011-10-26 00:00:00
The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and Georgeto... 


2011-10-26 00:00:00
FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tabl... 

FDA approves Onfi to treat severe type of seizures
2011-10-26 00:00:00
On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended t... 

Illinois warehouse Prevents unsafe food distribution from rodent-infested facility
2011-10-19 00:00:00
FDA: U.S. Marshals seize food products at U.S. Marshals, acting at the request of the FDA, seized various food products stored in a warehouse owned by Chetak Chicago LLC, in Streamwood, Ill., on October 17, 2011. The products were seized under a warr...