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  • ENGLISH
  • FRANCAIS
  • Services
    • Services Overview
    • Clinical Trial Operations
      • Protocol Development and Study Design
      • Feasibility and Study Start Up
      • Patient Recruitment
      • Project Management
      • Clinical Operations
      • Centralized Monitoring
      • Decentralized Clinical Trials (DCT)
      • Centralized eTMF
      • Medical Services
    • Regulatory and Drug Development Consulting
      • Clinical Strategy
      • Nonclinical
      • Chemistry, Manufacturing, and Controls (CMC)
      • Regulatory Affairs
      • GxP Strategy Consulting
      • Publishing and Submissions
      • Medical Writing
    • Government and Public Health Services
    • Biometrics
      • Biostatistics and Statistical Programming
      • Data Management
    • Clinical Pharmacology Modeling Simulation
      • Clinical Pharmacology Integrated Drug Development
      • Model Informed Dose & Drug Development (MIDD)
      • Pharmacometrics (PMx), Pharmacokinetics, Pharmacodynamics (PK/PD)
      • DMPK and Translational Discovery and Development
  • Therapeutic Expertise
    • Therapeutic Expertise Overview
    • By Subject
      • Oncology and Hematology
      • Rare Diseases and Orphan Drugs
      • Infectious Disease and Vaccine
      • Cell and Gene Therapy
      • Central Nervous System
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  1. Home
  2. Services
  3. Clinical Pharmacology Modeling Simulation
  4. Clinical Pharmacology Integrated Drug Development
  5. Regulatory Representation, Writing, and Submissions
    • Clinical Study Strategy and Design
    • Development and Regulatory Strategy
    • Regulatory Representation, Writing, and Submissions
    • Scientific/Technical Writing, Manuscripts, and Communication

Regulatory Representation, Writing, and Submissions

  • Clinical Pharmacology Integrated Drug Development
  • Clinical Study Strategy and Design
  • Development and Regulatory Strategy
  • Regulatory Representation, Writing, and Submissions
  • Scientific/Technical Writing, Manuscripts, and Communication

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)

 

Contact Us

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CONTACT US

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    • Oncology and Hematology
    • Rare Diseases and Orphan Drugs
    • Infectious Disease and Vaccine
    • Cell and Gene Therapy
    • Central Nervous System
    • Autoimmune and Inflammation
    • Allergy and Asthma
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