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Global Regulatory
Pharmaceuticals Consulting, Auditing and Training
30 July 2010

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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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

 

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
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For Immediate Release: July 22, 2010 FDA says Keystone kits are unapproved... 

RJR Consulting Registers with GlobalRegulatory.com
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GLobalRegulatory.com - The Regulatory Network! is pleased to announce that ... 

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

Press Release
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The U.S. Food and Drug Administration today approved the first generic vers... 

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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... 

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

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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 ... 

Submit Pharmaceutical News

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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!
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Intern
ational Regulatory News

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 version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used f... 

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 new drugs, and have not been proven safe and effective At the request o... 

RJR Consulting Registers with GlobalRegulatory.com
2010-07-19 00:00:00
GLobalRegulatory.com - The Regulatory Network! is pleased to announce that RJR Consulting Inc. has joined it's premier Network. RJR Consulting, In... 

Press Release
2008-02-06 00:00:00
The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies marketing unapproved injectable colch... 

Press Release
2008-02-06 00:00:00
The U.S. Food and Drug Administration today approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis, a... 

Press Release
2008-01-25 00:00:00
The U.S. Food and Drug Administration today issued an Early Communication regarding the agency's ongoing review of Vytorin based on preliminary result... 

Press Release
2008-01-18 00:00:00
The U.S. Food and Drug Administration (FDA) today approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to includ... 

Press Release
2008-01-16 00:00:00
On Jan. 2, the U.S. Food and Drug Administration (FDA) expanded the indication for a liquid fibrin sealant to help control bleeding during general sur... 

Press Release
2007-12-17 00:00:00
The U.S. Food and Drug Administration has approved Bystolic (nebivolol) for the treatment of high blood pressure. Bystolic is a beta blocker, a we... 

Press Release
2007-12-13 00:00:00
Orphan drug becomes first of its kind to treat this genetic disorder The U.S. Food and Drug Administration today approved Kuvan (sapropterin dihydr... 

Press Release
2007-11-19 00:00:00
The U.S. Food and Drug Administration today announced that it has approved Nexavar (sorafenib) for use in patients with a form of liver cancer known a... 

Press Release
2007-11-16 00:00:00
The U.S. Food and Drug Administration (FDA) today announced the board members and chair of the Reagan-Udall Foundation. The private and independent no... 

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