Chemistry Manufacturing and Controls (CMC)
Regulatory Support

CMC Regulatory support at every stage of development, registration and life cycle management.

 

BlueReg experts will provide your company with CMC Regulatory support at every stage of the development.

  • Assessment / definition of the CMC development strategy
  • Writing of CMC sections of briefing books for health authorities meetings
  • Assessment / preparation of regulatory documents:
    • Investigational New Drug (IND) application
    • Investigational Medicinal Product Dossier (IMPD)
    • Active Substance Master File (ASMF) / Drug Master File (DMF)
    • Certificate of Suitability to the European Pharmacopeia (CEP)
  • Responses to agency questions

Associated services

Scientific and CTD Dossier Writing

BlueReg provide flexible solutions for scientific writing covering all kinds of engagements or operational platforms to meet your company’s needs from product development, registration through to launch and product maintenance activities.  Our team are experienced in writing clinical modules for submission in the EU and the US, PIPs, ODDs, INDs, IMPDs and IBs, as well as briefing packages for scientific advice.  The team also manage Chemistry Manufacturing and Controls (CMC) writing for chemical and biological products.

Associated services

CMC Product Development

Looking for Chemistry, Manufacturing & Controls (CMC) expertiseBlueReg ensures CMC regulatory compliance for your projects to meet regulatory agencies requirements and expectations.

Associated services

CMC Regulatory support

Our CMC Regulatory support services include everything from regulatory strategy and preparation of meetings with health authorities, assessment and preparation of regulatory documents, responses to agency questions, maintenance of products on market, regulatory compliance strategy worldwide and geographical roll out.

Associated services

Preparation, writing and redaction of clinical study reports

BlueReg can support you with a highly experienced team of professsionals in preparing and writing of your clinical study reports, supporting the redaction proposal and document package for submission to the EMA to comply with EMA policy 0070.

Case study

Marketing Authorisation Holder Transfer for 60 MAs

Our client a global pharmaceutical and biotechnology company specialising in the research, development and marketing of medicines and vaccines for...

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