NDA / BLA Regulatory Experience

Nuventra’s focus on pharmacokinetics and clinical pharmacology has relevance throughout all phases of drug development. The combined regulatory experience of our consultants includes efforts on more than 120 NDAs.

Typical Nuventra services that may be utilized during NDA/BLA preparation and submission include:

  • Participation in pre-NDA meeting with the FDA.
  • Authoring pharmacokinetic and clinical pharmacology sections of NDAs/BLAs. Assistance with other NDA/BLA sections as needed.
  • integrated, cross-study pharmacokinetic analyses and reporting for inclusion in the NDA/BLA.
  • Population Pharmacokinetic/Pharmacodynamic (popPK/PD) analysis.
  • Modeling & Simulation
  • See our approach to summarizing scientific literature for regulatory submissions.

 

Read about an example of Nuventra authoring section 2.7.2 of an NDA:  CTD Section 2.7.2 relates to clinical pharmacology, pharmacokinetics (PK), and pharmacodynamics (PD), and PK/PD) is an important part of regulatory submissions.  Section 2.7.2 includes evaluation of the drug’s metabolism, effect of extrinsic factors (food-effect), effect of intrinsic factors (e.g., age, gender, ethnicity, body weight, renal and/or hepatic function, etc.) dose-response, exposure-response, and biomarker evaluation.  Having Nuventra produce Section 2.7.2 is the best option because of our fundamental understanding of the science and knowledge of PK, PD, PK/PD, and all clinical pharmacology studies.