Nuventra’s clinical pharmacology consultants and pharmacokinetic consultants have many years of experience authoring documents for submission to the FDA and other regulatory agencies. We have robust document templates and medical writing SOPs to allow for production of high quality, submission-ready documents.
Documents Nuventra prepares include:
- Clinical trial protocols and protocol amendments
- We have an extensive library of clinical pharmacology study designs, including special patient population studies (e.g., renal impaired, hepatic dysfunction, healthy elderly, thorough QT, radiolabeled mass balance, ADME studies, etc.).
- Clinical study reports (CSRs) with integrated PK and PK/PD data
- Robust PK and PD reports
- These PK and PD stand-alone reports can be attached to Clinical Study Reports as an appendix. Our stand-alone report structure has been used in numerous regulatory submissions. The structure of the report allows for the client to have an all encompassing PK, PD document that highlights the most important information but also contains all data needed for reproducing the pharmacokinetic and pharmacodynamic analyses.
- FDA and EMA marketing applications including New Drug Applications (NDA) and Biologics License Application (BLA)
- IND application preparation & maintenance
- Investigator brochure development and maintenance
- IMPD and international regulatory documents
- Conference abstracts and scientific posters
- Medical manuscripts and medical journal articles
- General scientific writing
Summarizing Scientific Literature for Regulatory Submissions
Assessing, analyzing, and summarizing data obtained from public databases such as PubMed, TOXNET, Embase, is a strength of Nuventra. Our consultants with advanced degrees are well versed in literature searches and evaluating peer-reviewed research articles from their efforts in graduate and post-graduate research.
Nuventra has worked on a series of unique INDs and a 505b(2) NDA for clients that were based solely on summary of literature articles obtained from public databases. The INDs were particularly novel and required buy-in from the FDA to base the IND and IND-enabling clinical studies solely on literature summaries. In fact, upon review of one literature-based IND the FDA medical reviewer had the following comment “This IND was written quite well and is a pleasure to read. Most interesting and novel”.
Our approach for including literature summaries in regulatory filings is to cast a broad net initially by searching for original publications and review articles. We refine search parameters based on a critical review of the results and narrow the pool of articles to those that are most relevant for the particular program. We use the literature database software package Endnote® by Thompson/Reuters to efficiently manage the literature articles and generate bibliographies.