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Regulatory Consulting Service Areas

Our regulatory consulting services include, but are not limited to, regulatory matters that are governed by the following global health authorities.

  • US FDA
  • EU (European Commission)
  • Health Canada
  • Korea MFDS
  • CFDA
  • Therapeutic Goods Administration (TGA), etc.

We also provide global and FDA training seminars in various areas of regulatory affairs, quality, clinical affairs and regulatory compliance through our educational forum at global compliance seminar.

Food

  • Food – labeling and quality

Drugs

  • Animal Drugs – approval process, regulatory compliance and quality
  • Human Drugs – labeling, advertising and promotion, regulatory documentation/submission,  approval process, cGMP, clinical endpoints/trials, data analysis, orphan drugs, many different types of human drugs to provide guidance and research direction, drug research and market trends
  • Compounding Pharmacy – regulatory compliance and quality (cGMP)

Cosmetics

  • Cosmetics – labeling and regulatory compliance
  • Tobacco Products – regulatory compliance

Medical Devices and IVDs

  • Medical Devices including In Vitro Diagnostic Devices
    • All global regulatory preparation and submission for pre-submission (Q-submission), IDEs, 510(k)s, FDA advisory committee meeting, PMAs, and petition/appeals, etc.
    • Quality (cGMP)
    • Clinical evaluation and clinical study/trial design
    • Regulatory compliance

Marketing and Promotion

  • Affiliate Sales and Marketing – for good quality products
  • Promotion and Advertising (NEW): surveillance services on social media for drug and device firms
  • Regulatory Compliance Matters: global and FDA inspection preparation and readiness, management, responses to 483s and remediation

Patents

  • Patent application/filing  by a licensed patent practitioner with the US Patent and Trademark Office

Clinical Trials

  • Clinical Trial Design and Data Analysis: clinical trials for drugs, biologics, and medical devices including IVDs

FDA Process and Matters

  • FDA Advisory Committee Meeting: preparation, logistics, outcomes, and analysis.
  • FDA Decision Making Process and Prediction for drugs and medical devices including IVDs.

Research Areas

  • Global regulatory intelligence – holistic approaches and strategy (systematic, integrated)
  • Global market trend analysis for medical devices and IVDs, drugs (generics) and healthcare products.
  • Pharmacovigilance (PV)
  • Adverse event reporting and complaint handling
  • Postmarket activities
  • Promotion and advertising
  • Labeling
  • Social media practices
  • Medical trends for product design and development

Last Updated: 2020-06-07