Development & Regulatory Consulting

Facilitating successful compliance throughout your product’s entire lifecycle

We offer comprehensive regulatory, clinical, and product development consulting services to help minimize your product's development time and maximize its time on the market. With global strategic expertise that extends from the U.S. to European, Asian, Canadian, and South American markets, our consultants provide the best solutions for both established and novel pharmaceutical dosage forms across a wide range of therapeutic areas. 

Catalent Benefits
  • Strategic, global approach to regulatory planning and product development
  • Global network of regulatory experts with local knowledge
  • Experience with established and novel pharmaceutical dosage forms
  • Expertise in a wide range of therapeutic categories
  • Track record of success with regulatory approvals
  • Continuity of service from the lab to market
Catalent Services 

Our global regulatory services meet a wide range of strategic situations:

  • Worldwide scientific and regulatory strategies
  • Project management
    • Product lifecycle management 
    • Providing compliance management and leading product-development advice on intellectual property, quality issues, line extensions, and generic development
    • Access to broad network of in-house specialized regulatory and development experts
    • General scientific advice
    • Non-clinical and clinical planning and project management
  • Regulatory submissions at investigational and marketing stages
    • Documentation
      • Generation, compilation, and/or maintenance of all types of regulatory documentation
      • Comprehensive, in-depth technical and medical writing
      • Information-research findings and expert opinion reports
    • Regulatory guidance
      • Guidelines for all phases of product development and document submissions
      • Development and coordination of worldwide submission objectives
      • Development strategies, responses to warning letters, inspections, and clinical events
      • Product development, intellectual property, quality issues, line extensions, and generic development
      • Liaison
        • Communicate with regulatory authorities
        • Long-term interactions with U.S.A., European, Asian, Canadian, and South American health authorities
      • Analysis
        • Product potential analysis
        • Product development planning
  • CTD compilation
  • Regulatory compliance and audit
    • We provide manufacturing, testing, and packaging audits as well as complete compliance/validation programs.
      • Worldwide cGMP plant audits (active pharmaceutical ingredients, drug products, biologics, medical devices)
      • Contract laboratory audits
      • Vendor qualification audits
      • Design of cGMP compliance programs, including Standard Operating Procedure (SOP) development
      • Pre-approval Inspection (PAI) readiness and compliance programs
      • Consultation regarding cGMP facility design
      • Data integrity audits
      • 21 CFR Part 11 compliance audits and programs
  • Technical and medical writing
  • Regulatory due diligence
  • Regulatory electronic publishing
    • Catalent expertise encompasses paper and electronic regulatory submissions, study reports, and publications.
    • Key services include:
      • Electronic submissions expertise
      • Extensive Common Technical Document (CTD) experience
      • Technical writing expertise
        • Highly comprehensive scientific reports to fundamental documentation for pre-market and post-market needs
  • Training workshops
    • We offer specialized trainings so you can benefit from our extensive pharmaceutical experience. 
      • Staff development
        • Processes and procedures that optimize regulatory submission success
      • Methodology
        • Each module focused on your particular learning objectives to ensure that learning outcomes support your strategic goals
      • Customized workshops
        • Access to our extensive library of workshops that include regulatory, clinical, and compliance topics
        • Special training designed to meet your particular requirements