Nuventra’s approach to regulatory affairs is to match regulatory expertise with scientific, clinical, nonclinical, and overall drug development expertise to support marketing approval and market acceptance.
Nuventra’s team of regulatory affairs professionals understand the statutes, key regulatory opinions, and procedures that make for successful interactions with regulatory authorities like the FDA. However, we also realize that this expertise is not enough. Equally important is the ability to generate well-written and succinct arguments that are grounded in proven scientific, regulatory, and overall drug development principles.
Combining expert regulatory advice with clear, evidence-based messaging increases the chances for a successful and efficient development program and approval process. Nuventra brings these qualities to your program as we look critically and strategically at all drug development activities supporting regulatory interactions.
Successful interactions with regulatory authorities are a critical component to a successful drug development program. We believe that this can be best achieved by a realistic strategic assessment of the strengths and weaknesses of each individual program.
In addition to our efforts “behind the scenes” of various submissions, we regularly attend meetings with the FDA for our clients (e.g., Pre-IND, end of Phase 1 [EoP1], end of Phase 2 [EoP2], pre-NDA, pre-BLA, and Type C meetings). Our consultants having participated in more than 100 such meetings involving diverse product classes and therapeutic areas.
Through these interactions, we have developed a keen understanding of current attitudes at the FDA, especially regarding clinical pharmacology and pharmacokinetics, but more broadly as well. Using this experience, we are able to determine issues of critical importance to the FDA and advise our clients on appropriate strategies to meet the challenges they face.
Our past interactions with the FDA include teleconferences, face-to-face meetings, and written correspondence with a wide array of FDA offices and divisions. We have also acted as primary regulatory contacts for US-based clients and as US Agents for international clients. Some examples of the offices and divisions within FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) with which we have interacted include:
- Cellular, Tissue and Gene Therapies (OCTGT)
- Hematology and Oncology Drug Products (OHOP)
- Orphan Products Development (OOPD)
- Anesthesia, Analgesia, and Addiction Products (DAAAP)
- Antiviral Drug Products (DAVP)
- Cardiovascular and Renal Drug Products (DCaRP)
- Gastroenterology and Inborn Errors Products (DGIEP)
- Metabolism and Endocrinology Products (DMEP)
- Neurology Products (DNP)
- Nonprescription Drug Products (DNDP)
- Pulmonary, Allergy, and Rheumatology Products (DPARP)
We offer full-service, electronic Common Technical Document (eCTD) submission support for our clients. Our process includes compilation and organization of the submission using a standardized submission software solution. We perform quality checks on each document within the submission to ensure compliance with established electronic document standards. Finally, we validate the combined submission before uploading it via FDA’s Electronic Submissions Gateway. During the publishing and submission process, we work closely with the client to ensure that the submission is complete and timely, and that it meets both the client’s and the FDA’s expectations.
Nuventra’s regulatory affairs professionals have the expertise to handle even the most challenging drug development programs. Our advantage over other regulatory affairs groups lies in the deep experience of our consultants across a wide array of product types, indications, and development strategies. Nuventra offers an extensive assortment of regulatory services, including:
- CTD / eCTD Modules 1 to 5
- Module 1 Administrative Information
- Module 2 Summaries
- Especially 2.4 Nonclinical Overview, 2.5 Clinical Overview, 2.6 Nonclinical Written and Tabulated Summaries, 2.7 Clinical Summary (2.7.1 and 2.7.2 Biopharmaceutics and Pharmacology),
- Module 3 Quality
- Module 4 Nonclinical Study Reports
- Module 5 Clinical Study Reports
- FDA / EMA / PMDA Meetings
- Full meeting management and attendance
- Briefing document preparation
- Attend FDA / EMA / PMDA meetings as a subject matter (SME) expert (clinical pharmacology/PK, toxicology, medical, regulatory, biostats expert representation at regulatory meetings)
- Investigator Brochure authoring and updates
- IND annual reports
- Clinical trial protocols and Clinical Study Reports (CSRs)
- Full electronic eCTD publishing services
- IND/NDA/BLA submissions (all modules)
- Orphan drug applications
- Drug naming applications (nonproprietary and proprietary)
- Pediatric Study Plans (PSPs) and Pediatric Investigational Plans (PIPs)
- Investigational Medicinal Product Dossiers (IMPD) and other international regulatory documents
- Other regulatory forms and applications
Nuventra has former FDA reviewers on staff who can provide essential “behind the curtain” insights on your program. If you are ready to learn how Nuventra can help you develop an efficient and effective regulatory strategy for your own program, please contact us today.