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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
      • Autoimmune and Inflammation
      • Allergy and Asthma
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  1. Home
  2. Services
  3. Regulatory and Drug Development Consulting
  4. Regulatory Affairs
    • Clinical Strategy
    • Nonclinical
    • Chemistry, Manufacturing, and Controls (CMC)
    • Regulatory Affairs
    • GxP Strategy Consulting
    • Publishing and Submissions
    • Medical Writing

Regulatory Affairs

  • Regulatory and Drug Development Consulting
  • Clinical Strategy
  • Nonclinical
  • Chemistry, Manufacturing, and Controls (CMC)
  • Regulatory Affairs
  • GxP Strategy Consulting
  • Publishing and Submissions
  • Medical Writing

Regulations are in constant flux, given continuous innovation in healthcare technologies and country- and region-specific adaptations. Our regulatory affairs team helps you navigate this dynamic landscape to ensure that your products and processes meet all relevant regulatory requirements.

Knowledge of the regulations is not enough. Familiarity with the various global regulatory groups and their preferences is essential to achieve the most efficient and successful outcomes. At Allucent, we have gained this fluency through frequent interactions with different regulatory sections, including FDA, Health Canada, EMA, MHRA, and agencies in APAC, often presenting innovative products to treat challenging indications.

Our team of regulatory experts, comprising top-notch experts with advanced degrees including Ph.D., Pharm.D., and M.D., has a long-standing reputation for excellence in regulatory strategy and submission preparation. We complete approximately 750 submissions of various types annually.

Allucent regulatory solutions include the following:

  • Regulatory strategy throughout the lifecycle of your product
  • Regulatory application authoring and preparation
  • Regulatory program and project management
  • Regulatory contact capabilities
  • Regulatory submissions

Choosing the right regulatory strategy can mean the difference between a streamlined approval process or a drawn-out, expensive process. We have the proven expertise to design effective regulatory strategies to ensure an efficient approval process. Our team efficiently translates that strategy into the right documents for regulatory agency review, including the following.

Regulatory development milestone meetings and interactions:

  • Application Orientation meetings (U.S. AOM)
  • Product development meetings
  • Pre-submission and pre-application meetings (U.S. FDA, EMA, Health Canada, MHRA, and regulators in APAC)
  • EMA-FDA Parallel Scientific Advice
  • Oncologic Drugs Advisory Committee meetings (U.S.)
  • Advisory Committee meetings (U.S.)
  • Recombinant DNA Advisory Committee (RAC) meetings
  • Special protocol assessments (SPAs)

Marketing approval submissions:

  • New Drug Application (U.S. NDA)
  • New Drug Submission (Health Canada NDS)
  • Medical Device Application (U.S., EU, Health Canada)
  • Marketing Authorization Application (EU, UK, APAC MAA)
  • Premarket Approval (PMA)

Pediatric development:

  • Pediatric Written Request for Exclusivity
  • Pediatric Study Plan (U.S. PSP)
  • Pediatric Investigational Plan (EU PIP)

Designations and expedited programs:

  • Fast Track Designation
  • Breakthrough Therapy Designation
  • Accelerated Approval
  • Priority Review Designations
  • Orphan Drug Designations
  • Priority Medicines (PRIME)
  • Innovative Licensing and Access Pathway (ILAP)
  • Request For Designation (RFD)
  • De Novo Classification Request

Clinical trial application submissions:

  • Investigational New Drug Application (IND)
  • Clinical Trial Application (CTA)

Contact Us

Let us partner with your team on bringing new therapies to light. Get in touch to get started.

CONTACT US

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    • Rare Diseases and Orphan Drugs
    • Infectious Disease and Vaccine
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North American Headquarters
2000 Centregreen Way
Suite 300
Cary, North Carolina 27513
+1 919-361-2286

United Kingdom Headquarters
1st Floor, One Station Square,
Bracknell, Berkshire
RG12 1QB United Kingdom
T: +44 (0) 1344 891121
F: +44 (0) 1344 890335

European Headquarters
Stationsplein Noord-Oost 438
1117 CL Schiphol
The Netherlands
+31 20-4350-580