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| Regulatory Consulting |
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| Regulatory Requests |
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The Regulatory Network.
USA - Canada - United Kingdom - Europe -South America - Australia - Africa - Russia - Asia - China - Pacific Rim
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| Serving such industries as Pharmaceuticals, Biotechnology, Medical Devices & In-Vitro Diagnostics, Healthcare, Food & Beverage, Clinical Trials, Nutraceuticals, Cosmetics, Animal Health, Electronics, Telecommunications, Chemicals, Energy, Engineering, Consumer Products, etc |
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REGULATORY CONSULTANTS -
10 Most Recent Registered Regulatory Consulting Firms |
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GRAC-LLC (Global Regulatory Affairs Consulting-LLC)
The global regulatory landscape continues to produce challenges for the pharmaceutical and medical device companies. Evolving regulatory requirements, data, document and submission standards have created a need of new and expanded skill sets for regulatory professionals.
The new regulatory professionals, in addition of their knowledge of regulations, need to integrate expertise in science and technologies, product development processes, policy and law, business and management, communication t |
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K Friedman Consulting
K Friedman Consulting provides regulatory approval services for manufacturers of prescription and over-the-counter pharmaceuticals and natural health products (NHP). K Friedman also provides clinical trial application assistance for those sponsors wishing to conduct studies at sites in Canada. In addition, K Friedman Consulting compiles post-marketing changes for approved versions of the above products.
K Friedman Consulting has helped sponsors in Canada, the United States and Europe with reg |
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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 audits/assessments. With six operating locations we are well placed to provide you with timely and cost effective professional services.
Our clients range from a five-person niche market manufacturer, to multi-national conglomerates and non-government organizations such as the United Nations. |
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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, medical devices and food supplements.
Del Corno & associati started its activity in 2001 as a response to the increasing demand of experience in regulatory affairs and business development of the pharmaceutical industry.
The company achieves its objectives by adhering and working to four criteria: |
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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, quality assurance audits on a global basis. Our team provides a comprehensive range of quality assurance services, including auditing, consulting, SOP development and training to pharmaceutical, biotechnology and healthcare industries who are involved in Clinical research and development. WHAT MAKES US D |
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QualitecFarma
"QualitecFarma® is one of the most recognized Scientific Regulatory Affairs consultancy company based in Madrid with more than ten years background experience in this field, having worked with most of the biggest pharmaceutical companies in Spain and abroad.
QualitecFarma® has expertise in all therapeutic areas and product types. We do offer full regulatory support with a comprehensive portfolio of regulatory services including:
Gap analyses for all submission types (Centralised, Decentr |
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Life Regulatory Affairs
Life Regulatory Affairs is a registered Canadian based company operating under Cindia Pro Inc., and is solely dedicated to provide consulting services for companies in pharmaceutical, biotech, medical device and natural health industries to fulfill their compliance and regulatory submissions in North America, European Union and India. |
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KD&A Pty Ltd
KD&A specialises in providing an extensive range of business and regulatory services to manufacturers of medical devices and in vitro diagnostics, sponsors and other organisations. Some of these services include:
* Regulatory Advice
* Technical Documentation
* Assistance with Quality Management System Development, Implementation, and Maintenance
* Medical Device Product Registration
Contact us for further information or a quote for your product. |
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Advanced Medicals Consortium
Advanced Medicals Consortium's vertical integration allows our clients the benefit of industry expertise in the Medical Device, Pharmaceuticals and Biotechnology domains. Our qualified national associates have experience and expertise communicating directly with the FDA regarding regulatory guidance, medical device submissions and post-marketing surveillance. We assist our clients through all phases of the regulatory process. Our team provides timely, concise and valuable expertise to clients re |
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RegRx Consulting, LLC
RegRx Consulting, LLC provides consulting services to US and foreign pharmaceutical companies who need assistance with development and commercial drug regulatory affairs.
We are a select group of highly skilled and experienced regulatory affairs professionals with over 50 years of combined experience with the US Food and Drug Administration and other regulatory authorities. |
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| REGULATORY REQUESTS - 5
Most Recent Regulatory Requests |
12-000048 -
Dietary Supplement company with some personal care products introducing a sunscreen product needs regulatory consultant for OTC compliance for sunscreen topical
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12-000047 -
China Regulatory Consultant needed to advise US automotive company on China REACH and Importation and Shipping Compliance
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12-000046 -
Europe Pharmaceutical regulatory consultant needed to advise on innovator for particular product in Europe
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12-000045 -
Regulatory Consultant needed for registering nutraceuticals for sale in Mexico.
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12-000044 -
Pharmaceutical Manufacturer needs Pharmaceutical Consultant needed for Local license holder service, NDA submission
Life cycle maintenance: variatiosn label updates
Review of promotional materials
local health authority interactions
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| REGULATORY CAREERS - 5 Most Recent Legal and Regulatory Job Openings |
![KEY RESPONSIBILITY:
Serve as a scientist for assigned preclinical research studies of basic to moderate complexity, to include study management, interpretation and reporting of study data, and assuring the regulatory compliance of these projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
With minimal guidance, serve as a as a study director (SD), project scientist (PS) and/or principal investigator (PI) in the direction and execution of assigned studies in compliance with GLP regulations]() Study Director General Toxicology
Suzhou Xishan Zhongke Drug Research & Development Co., Ltd. -.KEY RESPONSIBILITY:
Serve as a scientist for assigned preclinical research studies of basic to moderate complexity, to include study management, interpretation and reporting of study data, and assuring the regulatory compliance of these projects.
ESSENTIAL DUTIES AND R.. |
 Senior Program Officer, Quality Assurance and Regulatory, Vaccine Development
Sabin Vaccine Institute -.The position is primarily focused in preclinical vaccine development activities, including oversight/improvement of new/existing documentation systems/databases. Candidate will help in defining programmatic milestones and assessing critical resources/timelines. Duties incl.. |
![Plan, direct and coordinate the operational activities of the microbiology and analytical labs.
Maintain a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations.
Ensure quality systems are being applied in the performance and documentation of lab studies and production processes.
Ensure compliance with applicable quality and regulatory requirements (qualified/trained staff, validated equipment, proper documentation]() Laboratory Manager
Unicep Packaging, Inc. -.Plan, direct and coordinate the operational activities of the microbiology and analytical labs.
Maintain a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations.
Ensure quality systems are being .. |
 ANIMAL CARE (RESEARCH SUPPORT) SUPERVISOR
SNBL USA -. * Maintain Good Laboratory Practices (GLP)
* Monitor and assure that all regulatory and/or applicable documentation is appropriately recorded, filed and accessible for inspections, reports, etc.
* Ensure direct reports' compliance with departmental standard op.. |
PATHOLOGY SERVICES DIRECTOR
SNBL USA -.As a member of the leadership team, the Director, Pathology Services will be involved in activities including strategic planning, department goal setting, budgeting, and process improvement efforts with Lean Six Sigma. The Pathology Services Director will have responsibility.. |
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| REGULATORY EVENTS - 5 Most Recent Legal and Regulatory Training Courses and Conferences |
![South Korea: Navigating the Clinical Trial and Regulatory Environment - Webinar By GlobalCompliancePanel]() South Korea: Navigating the Clinical Trial and Regulatory Environment - Webinar By GlobalCompliancePanel
lobal Compliance Panel - Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceutical Products in South Korea. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in South Korea. Content will also include description... |
![Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel]() Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel
Global Compliance Panel - Overview: Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation exper... |
![Device Changes and the 510(k) - Webinar By GlobalCompliancePanel]() Device Changes and the 510(k) - Webinar By GlobalCompliancePanel
Global Compliance Panel - Overview: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
Areas Covered in the Session:
U.S. FDA device clearance / approval
FDA's and EU's emphasis
Product changes and filing a new 510(k) - who's responsible
Tracking and evaluating changes - the "tipping point"
Is the process "ris... |
![Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel]() Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel
Global Compliance Panel - Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Who Will Benefit: This we... |
![Proper Documentation of Risk Management for Compliance with ISO 14971]() Proper Documentation of Risk Management for Compliance with ISO 14971
Global Compliance Panel - Overview: There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard.
However, most manufacturers are only using one tool, FMEA. The other tools are being ignored with a result that often does not meet the requirements of ISO 14971. This presentation will deliver a practical discussion on t... |
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| Regulatory Requests Areas |
International Regulatory Submissions
Need regulatory consultants or attorneys for filing, preparing, or compiling regulatory submissions, applications, registrations, amendments, accreditations, amendments, approvals, licensures, and certifications specializing in pharmaceuticals, medical devices, food and beverages, biotechnology, nutraceuticals and cosmetics industries. Need regulatory consultants or attorneys for filing submissions such as US FDA Pharmaceutical New Drug Applications (NDA) , EU Common Technical Documents (CTD), FDA Biologics License Application (BLA),CE Marking, IND/CTEX, NDA/MAA, Investigational New Drug IND, Abbreviated New Drug Applications ANDA, Pre-Market Approvals, PMA, 510ks, Drug Master Files, DMF, Technical Files, Declaration of Conformity, DIN submissions, CE Marking, CLIA Waivers, etc.Find regulatory consultants and lawyers for all your Regulatory Submissions needs! Submit Regulatory Requests for Submission Services |
Regulatory Compliance
Need regulatory consultants or attorneys for regulatory compliance services such as evaluation of the compliance of pharmaceuticals, biopharmaceuticals, clinical trials, in-vitro diagnostics, combination products, medical devices, consumer products, animal drugs, cosmetics, nutraceuticals, food and beverages to international government regulations, laws, guidelines, and industry standards such as US FDA FD&C, Good Manufacturing Practices, GMP, Good Laboratory Practices GLP, Good Clinical Practices GCP, HAACP, Part 11, European Directives, Medical Device Directive MDD, EU EHS, In-Vitro Diagnostic Directive IVDD, CEN Standards, CE Marking, ICH Standards, ISO 9002, Health Canada, Japan Ministry of Health, Australia Therapeutic Goods Administration TGA , etc? Find regulatory consultants and attorneys for all your regulatory compliance needs! Submit Regulatory Requests for Compliance Services |
International Regulatory Auditing
Need regulatory consultants or auditors for conducting due diligence, internal audits, or supplier vendor audits such as Global Harmonization Task Force GHTF SG 4 Regulatory Audits, Good Manufacturing Practices GMP Audits, Good Laboratory Practices GLP Audits, Good clinical Practices Audits, Mock Food and Drug Administration Inspections, ISO Audits, Pharmaceutical Inspection Convention (PIC) Audits, Quality Audits, Vendor Qualification Audits, Software Quality Audits, Sarbanes-Oaxley Audits, HAACP Audits, etc.in the pharmaceuticals, biopharmaceuticasl, biotechnology, medical devices, in-vitro diagnostics, biologics, animal drug, clinical trial, nutraceuticals, dietary supplement, chemical, cosmetics and food and beverage industries. Find regulatory consultants and auditors for conducitng all your regulatory supplier vendor audits, internal audits and due diligence needs! Submit Regulatory Requests for Audit Services |
International Quality and Regulatory Training
Need regulatory consultants for in-house, off-site, or on-line regulatory and quality training programs, courses, webinars, conferences, or seminars such as Good Manufacturing Practices GMP training, Good Laboratory Practices GLP Training, Good Clinical Practices GCP training, ISO training, Common Technical Documents Training, Post Market Surveillance Training, CE Marking Training, EU Medical Device Directives MDDD Training, EU Clinical Trials Directive Training, Part 11 Training, Process Validation Training, Vendor Audit Training, Clinical Research Monitoring Training, Quality Systems Training, Pharmaceutical Development Training, EudraVigilance Training, HAACP training within the Pharmaceuticals, Biopharmaceuticals, Biomedical, Combination Products, Medical Devices, Biotechnology, In-Vitro Diagnostics, Clinical Trials, Food and Beverages, Veterinary Medicine, Nutraceuticals and Cosmetics Industries? Find regulatory consultants and trainers for all your regulatory and quality training! Submit Regulatory Requests for Training Services |
Quality Services Consulting
Need quality consultants for Quality Systems consulting such as FDA, Good Manufacturing Practices GMP, QSR, ISO, quality systems, quality assurance and quality control (QA & QC) quality plans, quality manuals, and quality standard operating procedures, master batch records, device master files, corrective and preventative action (CAPA) systems for the pharmaceutical, biopharmaceutical, combination products, clinical trial, healthcare, medical device, in-vitro diagnostic, biotechnology, animal drug, cosmetic, chemical, consumer product, dietary supplement and food and beverage industries? Find Quality consultants for all your quality systems consulting services! Submit Regulatory Requests for Quality Services |
Government Liasion
Need attorneys or regulatory consultants for government relation services such as liasion services, US Designated Agents, European Authorized Representative EAR, FDA inspection facilitation and remediation, FDA responses, FDA warning letters, FDA seizures, FDA recalls, FDA advisory meetings, etc. for the pharmaceuticals, biopharmaceuticals, combination products, clinical trials, healthcare, medical devices, in-vitro diagnostics, biotechnology, cosmetics, veterinary medicine, chemical, consumer products, dietary supplements and food & beverage industries? Find lawyers and regulatory consultants for all your government relations consulting! Submit Regulatory Requests for Government Liasion Services |
Recalls and Crisis Management
Did your manufacturing company have a product failure and needs to recall product? Has a regulatory body like the US FDA just issued a warning letter or maybe seizing your product? Need attorneys or regulatory consultants for Crisis and Risk Mananagement consulting such as recalls, medical device reports, safety alerts, product failures, vigilance, post market surveillance, crisis intervention, pharmacovigilance, public relations of pharmaceuticals, biopharmaceuticals, combination products, medical devices, in-vitro diagnostics, biologics, animal drugs, cosmetics, consumer products, food and nutraceutical recalls and safety alerts. Find lawyers and regulatory consultants for all your crisis management and risk management needs! Submit Regulatory Requests for Crisis Management Services |
Exportation and Importation Consulting
Need regulatory consultants, US designatd agents, attorneys or customs brokers for customs consulting, importation, exportation or shipping of materials, parts, equipment or finished regulated products such as Pharmaceuticals, Biopharmaceuticals, Biomedical, Combination Products, Medical Devices, Biotechnology, In-Vitro Diagnostics, Clinical Supplies, Food and Beverages, Animal Drugs, Consumer Products, Nutraceuticals, Manufacturing Equipment, Scientific Instruments, and Cosmetics within countries such as USA, Canada, Ireland, China, Japan, Australia, Mexico, Argentina, Brazil, France, Germany, Russia, Italy, United Kingdom, etc? Find regulatory consultants, US designated agents, attorneys, or custom brokers for all your exportation and importation needs! Submit Regulatory Requests for Export and Import Services |
Labeling and Promotional Materials Consulting
Need attorneys or regulatory consultants for development and evaluation of labeling and promotional materials for the regulated Pharmaceuticals, Biopharmaceuticals, Biomedical, Combination Products, Medical Devices, Biotechnology, In-Vitro Diagnostics, Clinical Supplies, Food and Beverages, Animal Drugs, Consumer Products, Nutraceuticals, and Cosmetics? Find independent regulatory consultants, regulatory consulting firms or lawyers for all your labeling and promotional materials needs! Submit Regulatory Requests for Labeling Services |
Scientific and Technical Consulting
Need scientists, engineers, and technical consultants for specific technical or scientific projects with computers, software devleopment, toxicology, cytology, industrial hygiene, microbiology, pharmacokinetics, molecular biology, statistics, bioengineering, pharmacogenomics, genetics engineering, animal science, physiology, histology, protein chemistry, virology, food chemistry, nutrition, immunology, etc.? Find scientists, engineers and technical consultants for all your scientific and technical consulting needs! <Submit Regulatory Requests for Scientific and Technical Services |
Qualification and Validation
Need quality consultants, technical consultants, regulatory consultants or engineers for project management, review, and implementation of Qualification and Validation Programs such as Equipment Validation ( IQ, OQ, PQ), Cleaning Validation, Methods Validation, Process Validation, Medical Device Design Validation, and Computer Validation (Part 11) or to ensuree validation compliance to EU Directive 98/79/EEC and 21 CFR 820 in the pharmaceuticals, in-vitro diagnostics, biopharmaceuticals, medical devices, combination products, in-vitro diagnostics, and veterinary medicine processing, shipping, testing, packaging, sterilization, and manufacturing such as fermentation, tabletting, lyophilization, bioprocessing, etc.? Find technical consultants, quality consultants, quality engineers, regulatory consultants or engineers for all your qualification and validation projects! Submit Regulatory Requests for Validation Services |
Regulatory Consulting
Need regulatory consultants or attorneys for regulatory consulting services such as US FDA Pharmaceutical New Drug Applications (NDA) , EU Common Technical Documents or FDA Biologics License Application BLA regulatory strategy development, regulatory submissions, approvals, certifications, and licenses, post market surveillance, regulatory compliance, labeling reviews, expert witnesses, regulatory audits, remediation, interim regulatory affairs management for the pharmaceuticals, biopharmaceuticals, combination products, medical devices, in-vitro diagnostics, biotechnology, food and beverages, healthcare, nutraceutical, veterinary medicine, chemical, consumer products, and cosmetics industries. Find Regulatory Consultants and Attorneys in areas such as USA, Canada, European Union, South America, India, Ireland, United Kingdom, Japan, Asia, Australia, China, etc. Submit Regulatory Requests for Consulting Services |
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International Regulatory News
FDA takes steps to protect public health Agency working with animal, drug and medical communities to promote judicious antimicrobial use
2012-04-11 00:00:00
The U.S. Food and Drug Administration announced today that it is taking three steps to protect public health and promote the judicious use of medically important antibiotics in food-producing animals.
Antimicrobial resistance occurs when bacteria...
Department of Justice enters consent decree with California seafood processor Company agrees to multiple actions to correct FDA food safety violations
2012-04-11 00:00:00
A California seafood importer and processor has agreed to a consent decree with the FDA that prevents the company from manufacturing or distributing fish or fish products until it has corrected conditions in its seafood processing facility alleged to...
FDA announces plans to pilot end-stage kidney disease technology in new program
2012-04-10 00:00:00
Innovation Pathway aims to reduce time and cost of bringing safe and effective, breakthrough technologies to patients
Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA's Innovation Pathway, ...
Akron Rubber Development Laboratory, Inc's Time Domain (TD) Nuclear Magnetic Resonance (NMR) Capabilities Expand to Help Meet Today's Quality Assurance Needs
2012-04-09 00:00:00
Akron, OH - Determining the state of cure of elastomeric materials is becoming more and more important to today's material development companies and parts manufacturers. Quality Assurance Managers, Production Managers and Material Development Engine...
Akron Rubber Development Laboratory, Inc Adds to Its Accreditation Independent High Pressure / High Temperature Aging, Rapid Gas Decompression (RGD) Testing and Service Life Prediction Capabilities for Materials Used in the Oil and Gas Industry
2012-04-09 00:00:00
Akron, OH - Polymer engineering and material qualification for oil and gas applications is a daily challenge for engineers as they deal with ever higher pressures and temperatures at new depths and in new gases. Akron Rubber Development Laboratory,...
FDA enters consent decree with cheese producer due to Listeria contamination
2012-04-09 00:00:00
Washington state cheese processor agrees to FDA food safety action
A Washington state cheese processor and distributor has agreed to keep its products off the market until they are proven safe for consumption as part of a consent decree of permane...
CLSI Publishes Revised Guideline on Nucleic Acid Amplification Assays for Molecular Hematopathology
2012-04-05 00:00:00
The Clinical and Laboratory Standards Institute (CLSI) recently published Wayne, Pennsylvania, USA-April 2012-Clinical and Laboratory Standards Institute (CLSI) recently published Nucleic Acid Amplification Assays for Molecular Hematopathology; Appro...
FDA proposes lower risk classification for certain tuberculosis tests
2012-04-04 00:00:00
Lower classification will support CDC recommendations
The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis (TB). This rule would lower the current...
Avomeen Analytical Services Renews Registration with Contract Laboratory .com
2012-04-03 00:00:00
Contract Laboratory Inc. is pleased to announce that Avomeen Analytical Services has become a member of its Laboratory Outsource Network - ContractLaboratory.com.
Avomeen Analytical Services is a full-service chemical testing laboratory specializi...
ARDL's Time Domain (TD) Nuclear Magnetic Resonance (NMR) Capabilities Expand to Help Meet Today's Quality Assurance Needs
2012-04-02 00:00:00
For Immediate Release: April 2, 2012
From:
2887 Gilchrist Road
Akron, OH 44305
p.330.794.6600 f.330.794.6610
www.ardl.com
ARDL's Time Domain (TD) Nuclear Magnetic Resonance (NMR) Capabilities Expand to Help Meet Today's Quality A...
Ramboll Finland Registers with Contract Laboratory .com
2012-04-02 00:00:00
Contract Laboratory Inc. is pleased to announce that Ramboll Finland has become a member of its Laboratory Outsource Network - ContractLaboratory.com.
Ramboll is a truly multi-disciplinary engineering, design and consultancy company working to mee...
New FDA guidance on considerations used in device approval, de novo decisions
2012-04-01 00:00:00
Clinical data, risks, benefits and patient risk tolerance outlined in process
The U.S. Food and Drug Administration today published a first-of-a-kind guidance1 for medical device manufacturers, describing how the benefits and risks of certain medi...
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