Regulatory affairs

Our 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.

While a key understanding of the FDA regulations, guidance documents, and procedural techniques (e.g., the proper eCTD publishing format) is important, it is equally as important to be able to summarize a well-written but succinct argument to the FDA grounded in proven scientific, clinical, nonclinical, CMC, and overall drug development strategies and principals that support the overall strategic message to the regulatory authorities.

SB strategic development consultants brings these qualities to your program as we look critically and strategically at all drug development activities supporting regulatory interactions.

FDA Meetings

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). Using this experience, we can determine issues of critical importance to the FDA and advise our clients on appropriate strategies to meet the challenges they face.

As part of our interactions with the FDA, our consultants have participated in teleconferences, face-to-face meetings, and written correspondence with FDA, EMEA and other regulatory agencies across the world. 

eCTD Publishing

In addition to our writing and consulting services, we also offer full-service, electronic Common Technical Document (eCTD) submission support for our clients. Through this service, we compile and organize a client’s submission using a standardized submission management software solution, perform quality checks on each constituent document to ensure compliance with established electronic document standards, validate the combined submission, and upload the validated submission to FDA’s Electronic Submissions Gateway (ESG).

Regulatory Services

• CTD / eCTD Modules 1 to 5

  • Module 1 Administrative Information

  • Module 2 Summaries- Particularly 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