FDA Consultants

FDA Consultants Services in United States

Looking for aU.S. FDA Regulatory Consultant? Focal Point Research is a highly experienced Regulatory Affairs & Quality Assurance Consulting Firm. Focal Point Research is considered a leader in scientific and regulatory compliance across many industries. Our expertise spans more than three decades in all aspects of scientific and regulatory affairs, manufacturing, quality assurance and product/consumer safety. With our expertise, we can assist in bringing your product to market successfully.

Focal Point Research offers the following
U.S. FDA Consulting Services

Cosmetic Consulting

  • Review Labels, Inserts, and Advertising for U.S. Compliance
  • Review ingredients for U.S. compliance with our proprietary software
  • Submit U.S. Voluntary Product Registrations
  • Design and commission product testing or clinical trials to establish claim support and product compatibility

Drug Consulting

  • Review Labels, Inserts, and Advertising for U.S. Compliance
  • Review ingredients for U.S. compliance with our proprietary software
  • Complete U.S. FDA electronic submissions for drug establishment registrations and drug listings; IND, NDA submissions
  • Manage post-approval changes
  • Host FDA Inspections and Drug cGMP Audits

Medical Device Consulting

  • Label Reviews and Classification of Medical Devices
  • 510K submissions to U.S. FDA
  • Prepare for FDA QSR audits and will provide pre-regulatory audit inspections

Medical Affairs and Adverse Event Reporting

  • Preparation of medical documents for healthcare professionals
  • Analysis of adverse events for cosmetics, drugs, devices, and supplements

Consumer Product Consulting

  • Review packaging and labeling for regulatory compliance
  • Evaluate consumer complaints and manufacturing quality systems

Packaging Development Consulting

  • Development of primary, secondary and tertiary packaging component
  • Label development, including review of labelling requirements for the U.S. market
  • Shelf life testing of package and product interactions using both analytical and sensory evaluation

CONTACT

The Focal Point Research team of consultants is ready to help with your scientific & regulatory needs. Our friendly staff include scientists from various disciplines, regulatory and packaging experts and administrative support. We are eager to help you.

We provide our expertise to various businesses located throughout Canada and the United States, such as Toronto, Montreal, New York, Los Angeles, and many more.

GIVE US A CALL

  • 181 Lakeshore Road E. Mississauga, ON
  • mail@focalpointresearch.net
  • 1 (905) 271 2709
  • www.focalpointresearch.net

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