Sen
Regulatory Services and Regualtory products such as Consulting, Document Management Systems, Regulatory Submission Software, Audits, Guidelines, Compliance, Training, Labeling Reviews, Import and Export, Guidance Materials, Submissions, Filings, Certifications Global Regulatory
  Login | Help
Find Regulatory Consultants for all your Needs!
CONSULTANTS : Register>>
The Regulatory Consulting Network
Submit Consulting Requests
View Consulting Requests
Regulatory Directories
Regulatory Careers
Regulatory Events
Regulatory Resources
Regulatory News

Account Management

Welcome!
You are not logged in.

Regulatory Consulting
Regulatory Requests
 
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
Triad Forensics - New Product Testing * Forensic Evidence Storage * Chain of Custody Documentation * Drug Screening and Confirmation Drugs of Abuse (DOT/Non-DOT) * Trace Evidence Analysis * Fire Debris Testing * Food and Beverage Testing Product Stability Testing (Shelf-Life) * Metals Analysis & Wear Metals Testing * Potable & Non-Potable Water Analysis Industrial Hygiene Testing * Environmental Monitoring * Air Quality Monitoring * Device Validation Studies Microbial Examination * Fuel Examination * Biodiesel Testing * Data Interpretation Services Compliant Method Development * Protocol Verification * Expert Witness Testimony Quality Assurance Monitoring and Pre-Regulatory Audits for Industry, Biotech, and Pharma Triad Forensics - Triad Forensics Laboratory Is: 1. The Only Full-service Internationally Compliant (ISO 17025) Testing Lab In The Piedmont Triad Region 2. The only Private Forensic Laboratory in the State o
KD&A Pty Ltd - Regulatory Strategy Creation Regulatory Advice; CE Marking, FDA, Health Canada, and Therapeutic Goods Administration (TGA) Technical Documentation Quality Management System Development, Implementation and Maintenance Medical Device Product Registration 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 servi
Advanced Medicals Consortium - Regulatory Submissions o FDA - IDE, HDE, HUD, NDA, 510(k), PMA & Combination products o EU - CE, IVDD, Design Dossier, MDD o Canadian Health Class I-IV, CMDR o Japanese Ministry of Health (MHLW)  Computer System Validation for Equipment, Processes and Products o IEEE, ISO/IEC, ISPE (GAMP4), SEI (Security, Software Development, & Auditing) o Integration Verification & Validation  Unit, Integration, and System Acceptance Testing  IOPD/Q's  Factory & System Acceptance Testing o Laboratory Systems (Chemistry, Assays, Automation & Robotics) o Full Validation cycle (Master Validation Plan) with complete validation documentation  Quality System Requirements (QSR), cGxP's o Development, integration and training of clients staff with Quality System Requirements o Audits (first and second party) internal, external, pre-FDA inspections, ISO 9001:2000 o Medical Device (21 CFR 820), ISO 13485 o Finished Pharmaceuticals (21CFR 210, 211) o Biologics (21 CFR 600) o Human Cell & Tissue (21CFR 1271)  Software Development, Test, Integration and Compliance (V&V) for Class II & III Medical Device  Risk Assessment and Management, Hazard Analysis ISO 14971 & 16085  Human Factor Engineering (AAMI HE48 and FDA)  Corrective and Preventative Action (CAPA)  DFMEA, FMEA, Gage Reliability and Repeatability (G,R&R), SPC & ANOVA  Method Validations for Pharmaceuticals, Medical Devices and Combination Products  IT Network & Infrastructure testing and verification, penetration testing, vulnerability assessments for Internet, Intranet and Extranets  Contract Manufacturing (Proto-types, small production up to 5000 units) in Class 10,000 clean-room 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 associ
RegRx Consulting, LLC - Drug Regulatory Affairs Services: Overall regulatory development strategy, Interactions with FDA and other regulatory authorities, Negotiating labeling with FDA, Maintaining INDs during development, Maintaining NDAs post approval, Review of advertising and promotional campaigns including new product launches, Review of press releases, Management of OIG/PhRMA Code compliance, Due diligence, US Agent services. Regulatory Applications: New Drug Applications (NDA), Investigational New Drug Applications (IND), Common Technical Documents (CTD), Clinical Trial Applications (CTA), Abbreviated New Drug Applications (ANDA), Orphan Drug Applications, Amendments, supplements, annual reports, safety reports, Registrations, drug listings, 505(b)2 applications 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 h
Riverpharm Regulatory Consultancy - Riverpharm Regulatory Consultancy -
K Friedman Consulting - Pharmaceutical Regulatory Affairs: Preparation of CTA (clinical trail applications), CTAA (clinical trial application amendments), NDS (new drug submissions), SNDS (supplemental new drug submissions), ANDS (abbreviated new drug submissions), post-approval changes (notifiable changes, SNDS), responses to Notices of Deficiency from Health Canada on all of the above, Development and preparation of product monographs. OTC Products: Preparation of DIN (drug identification number) applications, NHP (natural health product) license applications and site-license applications, complete response to IRN (information request notices) for NHP product license/site-license applications. Other Consulting Services: provide input on regulatory strategy for timing and content of submissions, provide input as expert witness in litigations involving patents or other issues related to NOC regulations in Canada. 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
Sirega - Regulatory strategy Pharmaceutical writing / CMC documentation:· CTAs/INDs: IMPDs · Scientific Advice: Briefing packages · Marketing authorization applications, Variations, Renewals: CTD Modul 3, Quality Overall Summaries (QOS) · Stability/Analytical Reports Regulatory strategy · Scientific translations: German - English, English - German, Swedish -English, Swedish - German Medicinal products covered: · NCEs, Generics · Biologicals, Biosimilars · Advanced Therapies medicinal Products (ATMPs) Sirega - Sirega is a regulatory affairs consultant with 10 years professional experience in the pharmaceutical industry. Sirega covers all kinds of medicinal products and has specialized in Biotechnology and
CanReg Inc. - Regulatory consulting for all stages of development. CanReg Inc. - CanReg is one of North America's largest consulting firms dedicated exclusively to regulatory affairs for life sciences companies. Our clients benefit from the extensive experience of more than 100 i
Medcore Consulting - EU regulations Training, APAC regulations Training, RUB regulations Training, compilation of complex submission files, submission files for suitability, compliance for GHTF, AHWP and ASEAN regulations, Training in STED and CSDT submission format,Risk Analysis and Essential Requirements / principles, Technical Documentation, Labelling and Language Compliance, Import/Export advice Medcore Consulting - MedCore Co., Ltd. is an independent European and Asian based regulatory consultancy company for the medical devices industry, with its headquarters in Bangkok, Thailand. The solid knowledge and exp
Amogha Pharma Consultancy - Amogha Pharma Consultancy - Amogha Pharma Consultancy was started by Gurudatta GG in Feb 2006 ,having a vast experience of 22 years in various areas of Pharma Industry. He has worked in Quality Control department, Quality ass
Reg Clarity Inc. - Key service areas include strategic planning and performance on all client regulatory and quality needs throughout the product lifecycle, from design inception (R&D) through formalized development and testing, regulatory interface for clinical trails and product submissions for market release. Primary service areas also include Quality Management System (QMS) design, assistance on internal audits and mock external audits, CA/PA resolution and closure, review of product labeling, advertising and promotional materials (including website content) and press releases; field actions and recalls; product obsolescence and data archival/document control requirements. RCI does not provide services related to clinical study design, clinical statistical analysis, GCP audits or design and development standards for individual device categories; these services are provided by specialist partner organizations. Reg Clarity Inc. - Reg Clarity Inc (RCI) serves medical device companies distributing product in the USA, Canada and Europe. Our expertise covers Class III (USA) implantable medical devices as well as lower risk and/or
Universal Regulatory, Inc - 1. Regulatory Strategy and Planning Strategic Interactions with Global Health Authorities - Pre-IND, EOP2, pre-NDA, Scientific Advice Preparation and review of regulatory submissions IND, CTA, DMF, NDA, MAA Non-Clinical, CMC, Clinical Amendments Orphan Drug Designation Special Protocol Assessments (SPA) Request for Fast Track Designation IND Annual Report, DMF Annual Update Target Product Profile Product Development Plans with Global Regulatory Considerations Regulatory Oversight on Project Teams Product Research and Review of Summary Basis of Approval 2. Regulatory Oversight of Worldwide Clinical Trials Authoring Responses to Questions from Global Health Authorities and Ethics Committees Review and Approval of Investigator Packages for Shipment of Clinical Trial Supplies 3. Due Diligence Providing Regulatory Representation on Due Diligence Teams for On Site/Remote Due-Diligence Activities Technology and Expert Regulatory History Research 4. Regulatory Operations Support Assembly of Regulatory Submissions Document Management of Regulatory Documents and Record of Correspondence with Health Authorities Project Management of Large, Multi-Volume, Multi-Disciplinary Submissions Universal Regulatory, Inc - Universal Regulatory Inc offers comprehensive consulting services in Regulatory Affairs by combining strong technical expertise in pharmaceutical development with knowledge of global regulatory enviro
Clinivation - Global Market Clearance Services, including strategic and operational market clearance program development, support, and execution. The clinivation Global xi enterprise solution for Market Clearance Management enables executives and their teams to address the challenges of execution, effective governance, and lean business performance in their global market clearance operations. Only clinivation Global xi accelerates the market clearance cycle to advance new worldwide revenue and achieve new milestones of enterprise value. Clinivation WorldView is the medical device and diagnostic industry's most comprehensive, authoritative, and up-to-date enterprise solution for On-Demand Global Regulatory Intelligence. Providing clear, step-by-step market clearance regulations, processes, and guidance for >99% of the world markets, only clinivation WorldView delivers tried-and-true intelligence from certified, practicing professionals with real-world experience. Clinivation - Clinivation is the leading provider of integrated solutions that enable global market clearance. Guided by our singular vision- "Excellence in Market Clearance"- clinivation accelerates the entire mar
Emergo Group - Consulting for European CE Marking, Technical Files, FDA 510(k) clearance, STED, Japan PAL, China SFDA approvals, and Canadian licenses and other international regulatory compliance issues. Assistance with US FDA Quality System Regulation and ISO 13485 consulting, QMS audits, Japanese quality system requirements, internal auditor training and other quality assurance services. Global in-country representation for: European Authorized Representative, China Legal Agent, Japan Marketing Authorization Holder (MAH), Mexico Registration Holder, US FDA Agent and Australia TGA Sponsor. We help find and qualify medical distributors in Europe, including France, Germany, UK, Italy and Spain and other EU countries plus Japan, Mexico, China, Australia, Canada and the USA. * SFDA Medical Device Approvals * Legal Agent and After Sales Agent Representation * CCC Mark Certification * Chinese Medical Distributor Search * Clinical Trial Consulting and Clinical Research in China (CRO) Documentation * FDA 510(k) Clearance for Medical Devices * FDA cGMP Quality System Implementation Consulting * US FDA Agent Representation * US Medical Distributor Search * FDA GMP Overview Training * FDA GMP Quality System Audits * FDA Form 483 or Warning Letter Response * FDA 513(g) Consulting for Medical Devices * ISO 14971:2007 Risk Management * Validation Consulting for Processes, Equipment and Software * Quality System Audits and Gap Analysis * Due Diligence Audits to Determine QA & RA Compliance * Internal Auditor Training (ISO 13485 and FDA QSR) * ISO 13485 Quality Management Systems Consulting * ISO 13485 Training * ISO 14971 Risk Management Consulting * ISO 14971 Training * Medical Device Classification Consulting * Quality Assurance & Regulatory Affairs Outsourcing * Software, Equipment and Process Validation Consulting Emergo Group - Emergo Group is an ISO registered medical device consulting firm. By focusing on providing outstanding customer service and value for our clients, we have grown to become one of the leading medical de
Medical Device Consultants - Medical Device Regulatory Strategy Development, FDA Pre IDE Support, FDA Submissions - 510k, PMA, IDE  FDA Registration and Device Listing  FDA U.S. Agent  Canadian Medical Device License Applications  EU Device Directives / CE Mark  EU Authorized Representative  Medical Device Clinical Trial Strategy / Study Design  Clinical Study Initiation / Project Management  Clinical Trial Monitoring  Clinical Trial Data Management  Clinical Report Preparation  SAS Programming / Statistical Analysis / Biostatistics  FDA Quality System Regulation (QSR)  ISO 13485 Compliance  ISO 14971 Risk Management  Quality Assurance Audits for Medical Device Manufacturers and Suppliers  Ongoing Postmarket Medical Device Compliance Medical Device Consultants - MDCI is a full-service consulting firm and contract research organization (CRO) that helps emerging and established firms commercialize novel and innovative medical devices, in vitro diagnostics, and
Pathwise - Whether you're facing an FDA warning letter, an uphill battle against the findings of a recent Audit, or wanting to improve quality and compliance, PathWise can help. We've worked with many companies in the Medical Device and Pharmaceutical device industries to solve problems such as: * Procedures not being correctly defined and/or documented. * Difficulty finding the root cause of a non-conformance - resulting in repeat investigations. * Communicating quality procedures beyond the QA department. * Investigations remaining open longer than policy allows. PathWise not only provides an outside perspective to these issues, we bring proven best-practices, tools, and processes. We've studied the best of the best in the life sciences field, and bring an intimate knowledge of the FDA regulation. Pathwise - PathWise focuses on a solution based approach to solving problems for our clients. The Life Science industry has been growing rapidly both domestically and internationally over the past 25 years. Wh
ALR Regulatory Consulting LLC - We provide the following services: * Global Regulatory Advice and Strategy * Expertise in Device Software, Complex Systems and Single-use Disposables * Regulatory Affairs Publishing - 510(k), IDE, PMA, Technical File, Design Dossier * Risk Analysis/Risk Management * Project Management * QS Development/Implementation * Auditing (Supplier, Internal, Gap Analysis) * Advertising and Promotion ALR Regulatory Consulting LLC - Why do you need ALR Regulatory Services, LLC? * Leverage our knowledge and experience * Security and Confidentiality * Wide Range of Regulatory Submissions and Compliance services inclu
Regulatory Insight, Inc. - Regulatory Insight, Inc. specializes in the following types of regulatory submissions: ] US FDA 510(k) Premarket Notifications (including Abbreviated & Special 510(k)'s) ] US FDA PMA Premarket Approval Applications (including PMA Supplements) ] US FDA De Novo Applications ] US FDA 513(g) submissions ] US FDA RFD Request for Designation submissions to the Office of Combination Products ] European MDD CE marking ] Health Canada Medical Device Licensing ] Australian Therapeutic Goods Administration (TGA) applications Regulatory Insight provides on-site training to company personnel in the following areas: ] Quality system requirements and procedures ] Performing internal audits ] Determining regulatory strategies for new products or changes to existing products ] Preparing and submitting a 510(k) or PMA ] Preparing and submitting a Canadian Medical Device License Application or a Technical File/Design Dossier ] Designing, running and analyze the results of a clinical study ] Any specific regulatory or compliance need that your company may have Regulatory Insight, Inc. - Regulatory Insight, Inc. is a consulting company that provides worldwide regulatory services to the medical device and IVD industries. Whether you are a large, established corporation or a small star
Enersol - FDA GMP Medical Device Testing, ISO Testing, condoms, gloves, syringes, luer fittings, catheters,IUDs, needles, tampons, hot water bottles, rubber bands, blood bags, infusion sets, female condoms, prophylactic dams, package seal integrity, rubber properties, density and hardness, plastic film, rubber insulating mats, hot water bottles... Enersol - ENERSOL exists to serve the global medical device industry through the innovation of advanced product testing instruments and equipment and the provision of the highest quality testing services.
L. Capote PA - Practice Areas Our practice areas include the following: 1. Dietary supplements 2. Food 3. Medical Devices 4. Cosmetics 5. OTC & Prescription Drugs 6. Customs and Border Protection 7. Corporate Law We are also knowledgeable in other issues of regulatory compliance such as the Federal Trade Commission, the Environmental Protection Agency, the Alcohol and Tobacco Tax and Trade Bureau, U.S. Consumer Product Safety Commission, and various state agencies. For more information on the above listed practice areas please look under practice areas. L. Capote PA - L. Capote, P.A. is a boutique law firm handling a wide array of regulatory compliance issues arising from various federal and state agencies including FDA, USDA, FTC, Customs and EPA. Our practice de
GlobalTox - GlobalTox - Since 1993 GlobalTox has been providing value to our clients by managing integrated analytical, toxicology and ecotoxicology testing programs in support of industries and regulators assessing chemical
Frost Biopharmaceutical Consulting - At Frost Biopharmaceutical Consulting (FBC) we provide expertise in regulatory affairs and compliance to companies large and small to assist them in getting their products to market as quickly as possible. Some specific activities we can provide are: Acting as a US agent for your IND or other FDA regulatory submission Writing and compiling your IND, or NDA/CTD Writing clinical study protocols and clinical study reports Preparing FDA Meeting requests and briefing documents Preparation of Orphan Drug designation Preparation of Frost Biopharmaceutical Consulting - FBC is a drug development consulting firm where every client receives personalized service to meet his specific needs. Since we are a small consulting firm, you will always know who will be doing the
Facilities Solution Group - FSG's commitment to integration, collaboration, and innovation is the common thread that runs through our practice areas of Healthcare, Science & Technology, University, Manufacturing and Public Private Partnerships. Services Provided: * ARCHITECTURE * ENGINEERING * INTERIOR ARCHITECTURE * LAND PLANNING * LABORATORY PLANNING * PROJECT MANAGEMENT * SIMULATION AND MANUFACTURING SYSTEM SERVICES Facilities Solution Group - The Facilities Solutions Group is a team of expert planners, architects, engineers, interior designers and project managers who are focused on facility functionality and profitability. Our first step
Trident Rx Consulting Services - Services: ·Regulatory Strategy Development for drugs, biologics and  devices ·GXP Quality Services (GMP/GLP/GCP auditing, mock  inspections, due diligence qualifications of facilities,  vendor certification and strategic development) ·Due diligence activities in support of the sale or  purchase of a product ·FDA Submission Planning and Development (VGDSs, INDs,  NDAs, 510Ks, PMAs, CTDs, ANDAs, Paper NDAs, Annual and  Periodic Reports, DMFs and MAFs) ·Regulatory Documentation Publishing ·FDA Liaison Activities ·Consultation on CMC issues ·Regulatory opinions on Clinical, Nonclinical and Medical  Device Issues ·CMC Report Writing ·Medical/Preclinical Writing ·Regulatory Review of Clinical, Nonclinical, and CMC  Documentation ·Regulatory Review of Medical Device Documentation ·On-site seminars and training Introducing the parallel track initiative to meet the expectations of the Critical Path as dictated by Global Regulatory Authorities, FDA, EMEA, and PDMA Trident Rx Consulting Services - Sydney Gilman, Ph.D., is a former FDA Chemistry reviewer. He spent 6 years at FDA in various CDER Therapeutic Drug Divisions of the Center for Drug Evaluation and Research with consulting ties to bot
Lütcke Consulting Gmbh - Lütcke Consulting Gmbh -
If you have any questions, please do not hesitate to contact us Toll-Free at 1-877-353-0451 or email us

Regulatory Consulting Requests

Need regulatory consultants ? Save time and money searching & find the regulatory consultants to meet all your needs at no charge!
Submit Regulatory Requests

Regulatory Consultants increase your international legal, quality and regulatory consulting business & find new clients with our Regulatory Requests
View Regulatory Requests

Fulfill your worldwide legal & regulatory service needs! Need legal & regulatory services such as consulting, audit, training, expert witness, expert testimony, regulatory affairs, regulatory strategy, product approvals, clinical trials, documentation management, regulatory submissions, certifications, licenses, legal reviews, export, import, government relations, recalls, regulatory compliance, validation, remediation, quality management, international representation, registered agents, quality assurance, quality systems, marketing, advertising, labeling reviews ? Find attorneys, lawyers, quality consultants and regulatory consultants at no charge. Submit your Regulatory Requests at no charge!
Submit Regulatory RFP Requests

Does your company provide legal or regulatory services ? Find llegal and regulatory services contracts and increase your business!
View Regulatory RequestsInternational Regulatory News

Error Occurred While Processing Request

Error Occurred While Processing Request

Error Diagnostic Information

QUERY

The QUERY attribute of the tag does not specify the name of an available query

The error occurred while processing an element with a general identifier of (CFOUTPUT), occupying document position (50:29) to (50:88) in the template file G:\HOME\HHW667\LABCLASS\NAV_RT_NEWS_10.CFM.

Date/Time: 07/30/10 01:45:11
Browser: CCBot/1.0 (+http://www.commoncrawl.org/bot.html)
Remote Address: 38.107.191.118