Regulatory Representation, Writing, and Submissions

Allucent combines expert regulatory advice with clear, evidence-based messaging that increases the chances for successful interactions with regulatory authorities. We look critically and strategically at all drug development activities (nonclinical and clinical) that support regulatory interactions and marketing approval with added expertise in clinical pharmacology and modeling. Successful interactions with regulatory authorities are critical and can be best achieved by a realistic strategic assessment of the strengths and gaps of each individual program. Equally important is the ability to generate well-written and succinct arguments that are grounded in proven scientific, regulatory, and overall drug development principles.

Through past regulatory interactions, we have developed a keen understanding of current attitudes at the FDA, especially regarding clinical pharmacology and modeling and simulation. Our advantage over other regulatory affairs groups lies in the deep experience we offer across a wide array of product types, indications, and development strategies. Our regulatory affairs professionals and former FDA reviewers across Allucent’s business units have the expertise to handle the most challenging drug development programs. Our writing teams have immense scientific, medical, and regulatory writing experience authoring a diverse array of submission documents for the FDA and other regulatory agencies.

Regulatory Representation, Writing, and Submission Services: 

  • Authoring  IND/NDA/BLA submissions (all modules), CTAs, 505(b)(2)s, BE Biowaivers, PIP/PSPs, briefing documents, product labeling, information requests, PMR, PMC, etc.,
  • Participation in agency meetings (e.g., Pre-IND, EOP2)
  • Comprehensive support, including full meeting management, attendance, briefing document preparation, and acting as subject matter expert (SME) at the meeting
  • Full-service eCTD publishing and submission support
  • CTD / eCTD Modules 1 to 5
    • m.2.7.1, m.2.7.2 and key contributor to m2.5 (biopharmaceutics, clinical pharmacology, dose justification) and certain sections of m2.7.3 and m2.7.4
  • Investigator Brochure (IB) authoring and updates
  • Briefing documents
  • Clinical trial/clinical pharmacology study protocols and Clinical study reports (CSRs)
  • PK/PD, TK, and population PK reports
  • Orphan drug applications
    • Fast Track, Breakthrough Therapy, Priority Review, Regenerative Medicine Advanced Therapy Applications
  • Drug naming applications (nonproprietary and proprietary)
  • Pediatric Study Plans (PSPs) and Pediatric Investigational Plans (PIPs)