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Global Regulatory
Pharmaceuticals Consulting, Auditing and Training
11 March 2010
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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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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

 

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... 

Press Release
2008-01-16 00:00:00
On Jan. 2, the U.S. Food and Drug Administration (FDA) expanded the indicat... 

Press Release
2007-12-17 00:00:00
The U.S. Food and Drug Administration has approved Bystolic (nebivolol) for... 

Press Release
2007-12-13 00:00:00
Orphan drug becomes first of its kind to treat this genetic disorder The... 

Press Release
2007-11-19 00:00:00
The U.S. Food and Drug Administration today announced that it has approved ... 

Press Release
2007-11-16 00:00:00
The U.S. Food and Drug Administration (FDA) today announced the board membe... 

Press Release
2007-11-06 00:00:00
WASHINGTON, D.C. (November 6, 2007) - The Biotechnology Industry Organizati... 

Press Release
2007-11-05 00:00:00
The U.S. Food and Drug Administration (FDA) today announced that, at the ag... 

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INTERNATIONAL REGULATORY NEWS

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Itasca, IL - October 7, 2009: Sterigenics International, a global leader in sterilization services for the medical device and pharmaceutical industri( read more).....
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LEUVEN, BELGIUM, October 29, 2009: The Board of Directors of Sterigenics International, the world's leading provider of contract sterilisation servic( read more).....
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Contract Laboratory.com - The Laboratory Outsource Network is pleased to announce that A. Daigger & Company has registered to become part of their pre( read more).....
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Contract Laboratory.com - The Laboratory Outsource Network is pleased to announce that Triad Forensics Laboratory has registered to become part of the( read more).....
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Research Triangle Park, NC and Tampa, FL (21 September 2009) - Magellan BioScience Group, Inc. (Magellan), a pioneer in innovative drug development f( read more).....
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AUK Technical Services LTD (ATS LTD www.auk.com) is pleased to announce that our client DigiCom Electronics, 5327 Jacuzzi Street, Unit 3N Richmond,( read more).....
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DAVIE, FL--(Marketwire - June 22, 2009) - Crystal3 Laboratories, Inc., an affiliate of Analytical Maintenance Services, Inc. (AMS) known throughout th( read more).....
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DAVIE, FL--(Marketwire - June 22, 2009) - Crystal3 Laboratories, Inc., an affiliate of Analytical Maintenance Services, Inc. (AMS) known throughout th( read more).....
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Oak Park, IL, May 18, 2009 - PreLabs, LLC, a Chicago-based contract research organization, is pleased to announce the addition of Stuart Knight as the( read more).....
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Oak Park, IL, October 1, 2008 - Biologic Safety Research Inc. (BSR) announced today it is joining PreLabs, LLC to expand its operations. The existing ( read more).....

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