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.

GIVE US A CALL

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

DROP US A LINE