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Good People Working on Good Projects with Good Process

Regulatory Affairs

Whether it is beginning with designing a regulatory strategy or just helping complete a few documents, Frestedt Incorporated has hands-on experience with regulatory bodies around the world including submissions and face-to-face interactions. We will help your team focus on the key priorities for the submissions and assure that all agency requirements are met. Our intention is to arm you with comprehensive, submission-ready information and documentation to set you on a course for regulatory approval.

It’s important to remember how medical writing and regulatory work go hand in hand. Our experts have the experience and knowledge related to regulatory medical writing, critical to an overall service, product or medical device. From planning and writing to the overall submission work and post market surveillance, the ability to support our clients through medical writing is imperative to delivering consistent messaging reinforced by data. Frestedt Inc. can plan, create and oversee the development of critical documentation to necessary for regulatory activities in compliance with company policies, notified bodies and international regulations.

View our CASE STUDIES to read how Frestedt Inc. has helped other industry leaders become successful in the challenging world of regulatory affairs.

  • IDEs, INDs, IVDs (for US and OUS)
  • NDA/505(b)(2)
  • PMA/510(k)
  • Clinical Evaluation Reports
  • Literature Abstraction and Reviews
  • Clinical Trial Documentation and Registration
  • Product Labeling
  • Preclinical Reports and Summaries
  • Pharmcokinetic, Pharmacodynamic Studies
  • Toxicology Analysis
  • ADME, Including Drug Interactions and Toxicokinetics
  • ITAs
  • CTAs

Please contact us at info@frestedt.com if you have questions or would like additional information.

Our Regulatory Affairs Management Capabilities:

  • Regulatory Strategies and Support: We will develop a comprehensive regulatory strategy based upon the geographic market desired and knowledge of the regulatory requirements of each country.
  • Regulatory Submissions: We will compile research materials, prepare submission documents, correspond with agencies and upon approval prepare reports and strategies.
  • Regulatory Body Negotiations: Interaction with regulatory bodies on behalf of the sponsor regarding regulatory path, inquiries, briefings, meetings and any correspondence