FDA Consulting

FDA Consultants

Looking for a U.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
FDA Consulting Services

Cosmetic Consulting
  • Review Labels, Inserts, Marketing Material and Advertising for U.S. Compliance
  • Review ingredients with our proprietary software for U.S. compliance including state specific requirements
  • Prepare and Submit Voluntary Cosmetic Registrations & state specific requirements
  • Design and commission product testing, clinical trials to establish claim support and product compatibly
OTC Drug Consulting
  • Review Labels, Inserts, Marketing Materials and Advertising for U.S. Compliance
  • Review ingredients for compliance with our proprietary software
  • Prepare and submit FDA Drug listings, NDC requests, IND, NDA, & ANDA
  • Drug Facility Listings
  • Setup and implement Drug GMP Quality Management System
  • Conduct GMP audits for FDA Compliance
Medical Device Consulting
  • Product Classification
  • Label, Manual, and Advertising Material Reviews
  • Prepare and Submit Applications (510k, PMA, IDE)
  • Quality System Regulation
  • Establishment registration and device listing submissions
Post Market Surveillance and Adverse Event Reporting
  • Preparation of adverse event reports & submissions to FDA
  • Analysis of adverse events for cosmetics, drugs, and devices
Consumer Product Consulting
  • Review packaging and labelling for regulatory compliance
  • Evaluate consumer complaints and manufacturing quality systems
Package Development Consulting
  • Development of primary, secondary and tertiary packaging components
  • 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

“Focal Point Research has consistently and professionally looked after regulatory and quality issues of our brand for years. Through a courteous and knowledgeable team, they have managed to navigate us through an ever changing regulatory landscape while maintaining our interests, and allowed us to correctly distribute and sell within Canada.”

“I have truly enjoyed working with you over the last 8 years! You and your team have been an amazing resource for me. I have always been impressed by the knowledge and professionalism of everyone at Focal Point, which is a true testament to your leadership.”

Connect With Us

The Focal Point Research team is ready to help with all of your scientific and regulatory needs.  Our team has the experience and expertise you need to see your product to market and we are eager to help you.