A VARIETY OF SPECIALTY SERVICES FOR VERY DIRECTED NEEDS

RegChoice-Other Support Services

Other Support Services

RegChoice has tremendous experience in both the regulated product industry and academia.  This combination is critical in tackling many projects, large and small.  We can provide a variety of specialty services for very directed needs.  With our backgrounds spanning bench laboratory through commercial research, RegChoice is equipped to handle your special project, whether it be literature searches/reviews, specific regulation issues, Ingredient suitability and determinations (e.g. inactive ingredients, food contact substances and additives, etc. ) marketing practices, product safety concerns and assessments, or even interacting with FDA regarding your Small Business Determination (SBD). We also currently teach in the University setting, so it is of utmost importance that we are up to date on the various research techniques and current regulatory issues affecting your products and company.

We have addressed client needs related to FDA and/or NIOSH policies and guidances issued in response to COVID-19 (SARS-CoV-2): surgical masks and respirators, surgical gowns and surgical isolation gowns, treatments, hand sanitizers and different types of testing kits.  RegChoice professionals have years of experience with these types of devices as well as drug/topical treatments, but also understand the details of emergency needs and FDA’s responses to submissions, such as during the COVID-19 pandemic.  We also aid in planning transitions when FDA lifts emergency policies so that clients can remain in compliance with FDA regulations.

Some Of Our Expertise Include:

  • Pharmacovigilance
  • Literature searches, reviews, and compilations
  • Scientific, medical, and technical writing
  • Writing for publications
  • Review of promotional labeling
  • Safety assessments
  • Response to recalls and seizures
  • Toxicology consulting
  • Ingredient assessments (e.g. food substance GRAS reviews, inactive ingredient reviews, etc.)
  • Pharmacokinetic consulting
  • Assisting with CRO issues
  • Designing/editing clinical trials and other protocols
  • Dear Healthcare Professional Letters
  • Citizen Petitions
  • SBD applications
  • Expert research, reports, and testimony related to: regulations, safety surveillance / pharmacovigilance / epidemiology, product development, product labeling, product defects, allowable marketing practices and various other regulatory and scientific issues

Contact RegChoice

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Call us

1-813-358-3303

Email us

[email protected]