Drug Product Regulatory Affairs Services 

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


Sound scientific justifications to reduce the time and cost impact 

Our team of more than 40 professionals is aligned with manufacturing sites around the globe and experienced in CMC dossier preparation. 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 drug product 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.


Access to DMFs or CEPs to facilitate your submission

Our pharmaceutical Regulatory Affairs team exchanges information with our subject matter experts from our product development, formulation, tech transfer & manufacturing daily. Such efficient communication lines across our development and manufacturing site network are particularly valuable for drug 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.


Explore regulatory considerations for rapid approval

Learn more from Jakob on navigating accelerated regulatory pathways.

Our streamlined CMC regulatory service approach, enables you to reach your global clinical trial or marketing authorization approval on accelerated timelines

Global Comprehensive CMC Development

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 pharmaceutical 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.

Our drug product Regulatory Affairs service team has the global presence and knowledge to assist you in working  with the FDAEMA, and PDMA as well as regulatory 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 CMC development strategy or detailed discussions. Typical pharmaceutical regulatory affairs services include:

  • Develop briefing books and support for regulatory authority meeting
  • Writing & review of CMC dossier / 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 CMC 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