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Regulatory Support Services


We offer regulatory affairs services for our manufacturing clients to help minimize product development time and accelerate product approval. Our expert team can provide guidance and potential solutions to regulatory hurdles. Catalent prepares over 150 agency submissions each year and is experienced in handling a wide range of therapeutic areas and project types, from small to large molecule, sterile to non-sterile, and NCEs to established dosage forms.

Customers are provided with a tailored regulatory package based on need and stage of development and are assigned a team that will work with them throughout the life of the project. We can work with a client’s internal or 3rd-party regulatory teams to review submissions to ensure alignment with Catalent’s services and regulatory requirements. Or we can provide a complete regulatory consulting solution with authoring and publishing services. Our experts help clients navigate the complex and evolving regulatory environment to facilitate successful and timely agency interactions.

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Utilizing Catalent as both your manufacturing and regulatory partner creates significant efficiencies, reducing time and error. No one knows our manufacturing sites, technologies, processes and personnel better than us, and when information is needed, or processes need to be altered, we can get to the heart of the matter faster. Additional Catalent benefits include:

  • Strategic, global approach to regulatory planning and product development
  • Global network of regulatory affairs experts with local knowledge
  • Expertise in a wide range of therapeutic categories
  • Track record of success with regulatory approvals
  • Optimized compliance throughout the product lifecycle

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Our team offers customized regulatory affairs services for global markets and support the full product lifecycle for products contract manufactured at Catalent.

Dossier Authoring Services
Regulatory submission CMC writing including

  • Investigational new drug applications (e.g., IND / INPD / CTA)
  • Marketing authorization applications (e.g., NDA / MAA / NDS)
  • Generic drug applications (e.g., ANDA / ANDS)
  • Biologics license applications (e.g., BLA)
  • Drug Master Files
  • Global expansion filing support documents for ROW submissions
  • Lifecycle submissions such as variations (e.g., CBE-0 / CBE-30 / PAS / sANDS), annual reports, renewals

Regulatory Support and Advice

  • Define regulatory requirements and recommendations for new products, regulatory filing strategies and post-approval changes
  • Regulatory review of QbD (Quality by Design) / QbR (Question based Review)
  • CMC Module 3 gap assessment (product development and existing dossiers)
  • CMC Module 3 pre-submission dossier review

Regulatory Publishing
Full publishing services available for FDA, EMA and many other international Health Authorities

  • eCTD and non-eCTD electronic submissions (NeeS)
  • Paper to eCTD conversions
  • Collation and compilation of complete dossiers Module 1 through 5
  • Submission to Health Authorities via electronic gateways

Health Authority Meetings
Prepare correspondence documents and participate in pivotal meetings with health authorities for Catalent technology development projects across the product development timeline.

Clinical Support and Clinical Labelling

  • Labeling assistance for clinical trial material (test and reference)
  • Regulatory label review for US, EU, Israel, Eastern Europe and Russia, Canada, Australia and New Zealand, Asia Pacific and Latin America
  • Translation and back-translation coordination