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Global Regulatory
Pharmaceuticals Consulting, Auditing and Training
04 February 2012
Account Management
Regulatory Consulting
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Find pharmaceuticals, medical devices, life sciences, biotechnology, food, biopharmaceuticals, healthcare, cosmetics, nutraceuticals consultants, attorneys for consulting, auditng and training services.
Pharmaceuticals Consultants
Pharmaceuticals Consulting, Auditing, and Training
  • Pharmaceutical Regulatory Submissions, Applications, Amendments, and Approvals such as
    • US FDA New Drug Applications (NDA)
    • US FDA Abbreviated New Drug Applications (ANDA)
    • US FDA Investigational New Drug (IND)
    • US FDA Drug Master Files (DMF)
    • Electronic Common Technical Document (eCTD)
    • Health Canada New Drug Submissions (NDS)
    • Pharmaceutical Annual Product Reviews
    • Orphan Drugs
  • Pharmaceutical Consulting Services
    • Pharmaceutical Regulatory Strategies
    • Pharmaceutical Regulatory Structure
    • Pharmaceutical Regulatory Affairs Staffing, Support and Management
  • Pharmaceutical Regulatory Compliance
      • US Food and Drug Administration (FDA) Pharmaceutical Laws, Guidances, and Regulations
      • Health Canada Pharmaceutical Laws, Guidances and Regulations
      • EU Pharmaceuticals Laws, Guidances, and Regulations
      • International Pharmaceutical Laws, Guidances and Regulations
      • Pharmaceutical Industry Standards and Guidance
  • Government Liasons and Meetings
    • US Food and Drug Administration (FDA) CDER Advisory and Compliance Meetings
    • Health Canada
    • European Union
  • Pharmaceutical Quality Assurance
    • Pharmaceutical Standard Operating Procedures (SOP) Development and Review
    • Pharmaceutical Quality Control and Quality Assurance Staffing and Management
    • Quality Manual
    • Pharmaceutical Production, Manufacturing, Packaging and Laboratory Controls
  • Pharmaceutical Audits
    • Pharmaceutical FDA Pre-Approval Inspections (PAI)
    • Pharmaceutical Mock FDA Inspections
    • Pharmaceutical Good Manufacturing Practices (GMP) Audits
    • ISO Audits
    • Good Laboratory Practices (GLP) Audits
    • Pharmaceutical Supplier and Vendor Audits and Vendor Certification
  • Pharmaceutical Training
    • Pharmaceutical Good Manufacturing Practices (GMP) Training
    • ISO Training
    • Good Laboratory Practices (GLP) Training
    • Good Clinical Practices (GCP) Training
    • EU Common Technical Document Training
    • Pharmaceutical Process Validation Training, etc.
  • Pharmaceutical Labeling and Promotional Materials
  • Pharmaceutical Equipment Qualification and Validation
    • IQ, OQ, PQ, DQ,
    • Process Validation
    • Pharmaceutical Cleaning Validation
    • Pharmaceutical Software Validation
    • Pharmaceutical Computer Systems Validation (SCADA, LIMS, etc)
    • Part 11
    • Pharmaceutical Qualification and Validation Protocols
    • Pharmaceutical Validation Execution
    • Pharmaceutical Validation Master Plans
  • Remediation
    • FDA Pharmaceutical Import Detentions
    • FDA Warning Letters and FDA-483's
  • Pharmaceutical Scientific and Technical Reviews
    • Pharmacokinetics
    • Pharmacovigilance
    • Biostatistics
  • Pharmaceutical Legal Expertise
    • Pharmaceutical Patents
    • Pharmceutical Expert Witnesses and Expert Testimony
  • Pharmaceutical Systems and Processes
    • Pharmaceutical Development
    • Pharmaceutical Formulation
    • Pharmaceutical Pre-Formulation
    • Pharmaceutical Bioprocessing and Synthesis
    • Pharmaceutical Manufacturing
    • Pharmaceutical Aseptic Filling
    • Pharmaceutical Sterilization
    • Pharmaceutical Packaging and Labeling
    • Pharmaceutical Storage, Shipping, and Distribution
    • Pharmaceutical Facility Systems
      • HVAC Air Handling Systems
      • Water Systems
    • Pharmaceutical Technology Transfer and Scale-up
  • Government Information Requests
    • US Freedom of Information(FOI) Act Requests
  • Pharmceutical Project Management
  • Pharmaceutical Expert Witnesses
  • Pharmaceutical Technical Writing
  • Pharmaceutical Scientific Reviews
  • Pharmaceutical Pharmaceutical Legal Services
  • Pharmaceutical Clinical Trials Consulting Services
    • Pharmaceutical Preclinical and Clinical Trial Design
    • Pharmaceutical Clinical Trial Monitoring
    • Evaluation of Pharmaceutical Clinical Data

Global Regulatory .com can assist your pharmaceuticals manufacturer, packager, distributor in finding Pharmaceuticals Consultants with specialization with products such astopicals, opthalmics, generics, parenterals, ointments, combination products, capsules, tablets, OTC, orphan drugs, liquids, antidepressants, antipsychotics, anti-convulsants, anti-infectives anesthetic drugs, antivirals, antibiotic, corticosteriod, cholinergic agonists, anticholinergics, adrenergics, antimicrobials, antiseptics, penicillins , cephalosporins, antihypertensive, sulfonamides, antifungals, antiprotozoals, antihelminthics, antiarrhythmics, inotropics, antihypertensives, antitussives, expectorants and mucolytics, immunosuppressives, alkalating agents, Inhalation and Intravenous anesthesia, Local anesthetics, opioids, antiepileptics, muscle relaxants, hypnotics, sedatives, amphetamines, anorexogenics and CNS stimulants, anxiolytics, hematinics, anticoagulants, thrombolytics, hstamine / antihistamines, eicosanoids, nonsteroidal anti-inflammatories, antisecretories, laxatives, antibacterials, adrenocorticoids, progestins, antiandrogens, antidiabetic agents, etc. etc.

Global Regulatory .com can assist your pharmaceuticals manufacturer, packager, distributor in finding Pharmaceuticals Consultants in countries or areas such as New Jersey, New York, California, Florida, Arizona, Texas, USA, Vancouver, British Columbia, Toronto Canada, Puerto Rico, Brazil, Argentina, Venezuela, South America, Mexico, Mumbai, New Delhi, India, Madrid, Spain, London, England, United Kingdom, Dublin, Ireland, Sydney, Australia, Africa, Japan, China, etc.

Global Regulatory .com can assist your pharmaceuticals manufacturer, laboratory, packager, distributors in finding Pharmaceuticals Consultants with special certifications, licenses, education, degrees, knowledge, experience or skills such as Pharmacologist, Toxicologist, Manufacturing, Statistics, Mixing, Architects, Engineers, Tabletting, Microbiology, Packaging, Formulation, Chemists, Physicians, Nurses, Bioengineering, Project Managers, RAC, PhD, Chinese, Japanese, Spanish, French, German, Attorneys, JD, etc.

If you require additional information , please do not hesitate to call us at 403-770-1994 or email us.

Need to find regulatory consultants or attorneys? Global Regulatory.com can help you find regulatory consultants or attorneys in such industries as Pharmaceuticals, Medical Devices, Biologics, Food and Beverages, Cosmetics, Life Sciences, Nutraceuticals, Veterinary Medicine, Electronics, Plastics, Chemicals, Telecommunications, Environmental, Automotive, Aerospace, Consumer Products, Construction, Oil and Petroleum, Transportation, Power and Energy, Medicine, Agriculture, Nuclear, Healthcare, etc. Simply, Submit Regulatory Requests for Proposals

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Submit Pharmaceutical Regulatory and Quality Requests.
Global Regulatory .com can assist your company in finding Regulatory Consultants for legal and regulatory services such as submissions, certifications, licensing, quality systems, technical writing, importing / exporting, expert witnesses, audits, consulting, scientific reviews, designated agents, compliance, validation, qualification, training, etc in industries such as:

 

Pharmaceutical News

 


2011-10-26 00:00:00
FDA approves first generic olanzapine to treat schizophrenia, bipolar disor... 

FDA commissioner outlines steps to spur biomedical innovation, improve health of Americans
2011-10-05 00:00:00
FDA Commissioner Margaret A. Hamburg, M.D., today released a blueprint cont... 

Novel anthrax vaccine and antitoxin being developed with federal support
2011-09-15 00:00:00
BARDA contracts will expand the tools available to protect the nation in a ... 

US Food and Drug Administrations US FDA, international counterparts report progress on drug inspection collaboration
2011-08-03 00:00:00
The U.S. Food and Drug Administration, together with its European and Austr... 

FDA Approves First Generic Enoxaparin Sodium Injection
2010-07-23 00:00:00
The U.S. Food and Drug Administration today approved the first generic vers... 

Federal Government Seizes Cyanide Antidote Kits from California Company
2010-07-22 00:00:00
For Immediate Release: July 22, 2010 FDA says Keystone kits are unapproved... 

RJR Consulting Registers with GlobalRegulatory.com
2010-07-19 00:00:00
GLobalRegulatory.com - The Regulatory Network! is pleased to announce that ... 

Press Release
2008-02-06 00:00:00
The U.S. Food and Drug Administration today announced its intention to take... 

Press Release
2008-02-06 00:00:00
The U.S. Food and Drug Administration today approved the first generic vers... 

Press Release
2008-01-25 00:00:00
The U.S. Food and Drug Administration today issued an Early Communication r... 

Press Release
2008-01-18 00:00:00
The U.S. Food and Drug Administration (FDA) today approved additional chang... 

Submit Pharmaceutical News

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... 

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