Regulatory Affairs

Our regulatory affairs specialists have years of experience working with the FDA throughout the pharmaceutical, biotechnology, medical device, and diagnostic industries. We carefully consider all strategies and alternatives during each step of the regulatory process, helping you register products without costly delays.

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Regulatory Consulting Services

We will work with you in both pre- and post-marketing drug safety regulations, regulatory filings, marketing authorization applications, variations and renewals, and assist in carefully developing due diligence strategies. Our regulatory experts manage the entire registration process for new drugs, biologics, generic products, and medical devices.

  • Review of client technical dossiers and developmental plans
  • Research and interpretation of regulations
  • Determination of regulatory status
  • Pre-submission review of technical documents
  • Critical writing and review of documentation
  • Clinical trial applications and notifications for Investigational Device Exemptions (IDE)
  • Marketing Application Support for New Drug Applications (NDA), Biologics License Applications (BLA), Abbreviated New Drug Applications (ANDA), 510(k) Approvals, Premarket Approval (PMA), etc.
  • Orphan Drug, Treatment Use, and ANDA Suitability petitions

Regulatory Submissions & Quality Control

The FDA Group prepares all major regulatory submissions and provides extensive quality control review for all trial-related documentation, such as:

  • Regulatory Agency and IRB/EC submissions
  • Procurement of Import/Export license
  • Initial submissions, amendments, notifications, and closeout submissions

Our regulatory affairs specialists coordinate all aspects of your trial’s document collection and submissions, including:

  • Managing all regulatory documentation as part of the start-up, conduct, and close-out phases
  • Coordinating clinical trial application filings to regulatory agencies
  • Ensuring submissions comply with regulations
  • Managing submissions and document storage processes
  • Staying abreast of all regulations to ensure documentation compliance

Our team of experienced regulatory scientists can write the nonclinical, clinical, and Chemistry, Manufacturing, and Controls (CMC) sections in Common Technical Document (CTD) and traditional format for your new drug and biologic applications.

Our Regulatory Experience

The FDA Group’s experience encompasses FDA clinical trial applications and registrations of medical devices, new chemical and biological entities, as well as those products containing established pharmaceutical ingredients (generics and 505(b)(2) products). We develop high-level regulatory strategies to expedite products through clinical trials and into the market, and regularly represent our clients in meetings with the FDA.

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Our white paper offers a helpful look into effective CAPA and root cause analysis in FDA-regulated industries.

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Contact us today to learn more about our regulatory affairs services.