Regulatory affairs services 

In close collaboration with you, our Regulatory Affairs provide a CMC dossier suitable to the stage of clinical development of your product manufactured by us.

Our team of more than 40 professionals is aligned with manufacturing sites around the globe. We excel in writing and facilitating responses to questions raised by global health authorities for clinical trial and license applications. We have worked together with our customers to apply sound scientific justifications to reduce the time and cost impact. We systematically track regulatory trends and topics for the extensive number of our facilitated health authority assessments, and we apply this information towards writing your application. FDA/EMA CMC compliant templates are utilized (with internal guidance to capture all required regulatory information) as part of our customer-based quality system.

Our Regulatory team exchanges information with our subject matter experts from our product development, formulation, tech transfer & manufacturing on a daily basis. Such efficient communication lines across the our development and manufacturing site network are particularly valuable for products where an accelerated regulatory pathway has been granted.

In addition to supporting drug products developed and manufactured by us, we provide regulatory information for our media and capsules, and offer access to DMFs or CEPs to facilitate your submission.

Our streamlined CMC regulatory service approach, enables you to reach your global clinical trial or marketing authorization approval within the agreed project plan

A comprehensive offer, globally

Our Regulatory Affairs Services will ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. This regulatory strategy takes into account the stage of development and the countries in which you plan to file. The strategy will further ensure you have the required data to facilitate and support your global applications.

We have the global presence and knowledge to assist you in working  with FDAEMAPDMA and also with agencies in emerging markets such as in Latin America and Asia.

Early adaptation is key to avoid delays as we comply with our timelines. We strive to achieve a mutual understanding of risks and willingness to meet development challenges. This is particularly important to keep pace with regulatory thinking in emerging therapies and new technologies.

Our Regulatory Affairs Services communicate transparently keeping you continuously informed from the initial project kick-off meeting and subsequent interactions to facilitate any strategy or detailed discussions. Typical services include:

  • Develop briefing books and support for regulatory authority meeting
  • Writing & review of CMC / quality sections for global clinical trial applications
  • Provide the final IMPD and IND CMC section in the desired format and facilitate any response to CMC questions raised for the clinical trial applications
  • Writing & review of commercial eCTD 3.2.S/P and 3.2.A.1 and 3.2.A.2 to support global MAA/NDA/BLA/ANDA through product life cycle

In cases where your drug substance or drug product is tech transferred into Lonza the same principles will apply where we will work together to ensure the design of an appropriate regulatory strategy and accompanying dossier support.

  • Chemistry, Manufacturing, and Controls (CMC)
  • Investigational New Drug (IND)
  • Investigational Medicinal Product Dossier (IMPD)
  • Biologics License Application (BLA)
  • New Drug Application (NDA)
  • Marketing Authorisation Application (MAA)
  • European Medicines Agency (EMA)
  • Food and Drug Administration (FDA)
  • Certificate of Suitability (CEP)
  • Drug Master File (DMF)
  • Active Substance Master File (ASMF)
  • Active Pharmaceutical Ingredient (API)
  • Pharmaceuticals and Medical Devices Agency (PMDA, Japan)
  • National Medical Products Administration (NMPA, China)
  • Abbreviated New Drug Application (ANDA)
  • Prior Approval Supplement (PAS)
  • electronic Common Technical Document (eCTD)

In the past 5 years, our regulatory services have successfully provided the complete CMC documentation for:

more than 85 new chemical and biological (IND) clinical trial applications
more than 15 biological full BLA / MAA including products with Breakthrough or PRIME designation
more than 50 chemical MAA / NDA / DMF / ASMFs