PLG ensures a solid foundation for your CMC module

Chemistry manufacturing and control services (CMC) is a broad discipline encompassing development and life cycle management (LCM). The experts in this domain must be skilled in understanding the nature of the manufactured product, its regulations, and quality, efficacy, and safety aspects. Working with clients worldwide and understanding their pain points has allowed PLG to create a set of services in CMC related to the registration process and LCM that is included as part of the over-arching regulatory affairs landscape. Before and after the marketing authorization application (MAA), your dossier must be “bulletproof”; the CMC services below are designed to help you get there. 

PLG’s support for CMC encompasses

  • Due diligence of R&D, manufacturing, technology transfer data, and/or module 3 documents for various regulatory submissions (CMC HealthChek™)
  • Authoring briefing documents for scientific advice meetings or controlled correspondence with health agencies
  • Authoring of investigational medicinal product dossier (IMPD) for clinical trial applications (CTA) or investigational new drug (IND) application  
  • Authoring of active substance master file (ASMF)/drug master file (DMF) and certificate of suitability (CEP) applications   
  • Authoring quality overall summary (CTD Module 2.3 – QOS) and CTD Module 3 sections for new registration applications (new MAA, NDA/ANDA, BLA)
  • Change control assessment and update of CTD Module 2.3 – QOS and CTD Module 3 sections for life cycle maintenance activities, including renewals, variations, and post-approval supplements
  • Authoring specific scientific modules, including: elemental impurities, residual solvents, nitrosamine assessment reports, biowaiver justification, normative documents (EAEU countries), and for CPID-CE (Canada)
  • Authoring responses to deficiencies raised by authorities during regulatory submissions
  • Preparing dossier baselines  
  • Performing regulatory compliance exercises on the registered dossier against the current manufacturing practice
  • Conversion of CTD module 2 and 3 data to ACTD or national formats and vice versa
  • Program management of manufacturing site change and technology transfer activities  

PLG’s expertise in CMC ensures tangible benefits for our clients

PLG has in-house experts who have worked on many product types and pharmaceutical forms, including new chemical/biological entities, small and large molecules, parenterals, microspheres, and many more. Our scientific knowledge and keen understanding of the regulations give our teams the edge in supporting our clients’ needs. 

Knowledge and expertise are part of our DNA. Project management, good communication, and understanding of client needs give PLG the key to meeting client expectations and leading to success. 

KEY FIGURES

200+

Module 3s reviewed and authored.

20

BLA, IND, and IMPDs have been authored by PLG.

100

Due diligence has been conducted for product acquisition.