Regulatory Interactions & Submissions

Nuventra has extensive regulatory affairs experience related to clinical pharmacology and pharmacokinetics.  We regularly attend meetings with the FDA for clients (e.g., Pre-IND, end of Phase 1 (EoP1), end of Phase 2 (EoP2), pre-NDA, and Type C meetings).  We are familiar with the regulatory guidance documents for clinical pharmacology and PK and also understand the current environment at the FDA related to clinical pharmacology and PK topics across many different therapeutic areas.

Nuventra personnel have had numerous interactions with FDA (CDER and CBER) across multiple Divisions and are experienced in determining issues of critical importance to FDA and advising clients on appropriate strategies to meet the challenges. Division within CDER for which we have interacted with include the Divisions of Anesthesia, Analgesia, and Addiction Products (DAAAP), Metabolism and Endocrinology Products (DMEP), Pulmonary, Allergy, and Rheumatology Products (DPARP), Cardiovascular and Renal Drug Products, Gastroenterology, and Neuropharm. Offices for which we have interacted with include the Offices of Hematology Oncology Drug Products, Orphan Products, Nonprescription Products (OTC).

The combined regulatory experience of our consultants includes efforts on approximately 50 IND projects and 20 NDAs. Our collective exposure to FDA has included participation in over 75 meetings with the Agency across diverse projects and therapeutic areas and Divisions. Regulatory writing experience spans large numbers of Investigator brochures, clinical study reports, clinical protocols, meeting briefing packets, IND annual reports, IND safety reports, etc.

Regulatory submissions that we support include focusing on the clinical pharmacology and pharmacokinetic sections of the following:

  • Briefing packets for pre-IND, end of Phase 1 (EoP1), end of Phase 2 (EoP2), pre-NDA, and Type C meetings.
  • Full IND preparation and maintenance as well as targeted efforts on clinical pharmacology, human PK/PD, and nonclinical ADME and toxicokinetic sections.
  • Investigator Brochure authoring and updates.
  • IMPD and international regulatory documents.
  • NDA/BLA/CTD components (including CTD Module 2)

 

Read about an example of Nuventra authoring section 2.7.2 of an NDA.