Chemistry, Manufacturing, and Controls (CMC)

Mastering the complexities of Chemistry, Manufacturing, and Controls (CMC) requirements is essential for successful drug development. We offer thorough CMC regulatory support, backed by extensive industry experience (over 150 years in total) and a proven history of success (see testimonial page).

Drug Master Files (ASMF, CEP) writing and gap assessment ›

Drug Master Files (DMFs) and Active Substance Master Files (ASMFs) are critical components of your pharmaceutical operations. These documents contain comprehensive details about the chemistry, manufacturing, and controls (CMC) of your active pharmaceutical ingredients (APIs). They include essential information on synthesis, purification, packaging, and stability.

CMC Drug Development Support ›

Effective regulatory strategy is paramount in every stage of drug development, particularly in the critical phases of Chemistry, Manufacturing, and Controls. From early development to commercialization, we offer strategic guidance and hands-on support to ensure your product meets regulatory requirements and quality standards.

Due diligence ›

Due diligence assessment involves a thorough analysis of the product development strategies and data to identify gaps, deficiencies, and risks- ensuring compliance with applicable regulations and industry standards.

Gap assessment ›

Conducting a gap assessment of pre-approval regulatory files is important to ensure regulatory success. This effective method pinpoints discrepancies between your existing documentation and stringent marketing authorization requirements.

Technical Writing ›

CMC technical writing involves the creation of texts on chemistry, manufacturing and controls of drug substances and drug products. These sections are typically part of Module 2.3 Quality Overall Summary (QOS) and Module 3 of the common technical document (CTD).

Agency Interactions ›

Navigating the regulatory landscape is crucial to the successful development and commercialization of pharmaceuticals and biopharmaceuticals.

Comprehensive Regulatory CMC Support from Development to Market

Mastering the complexities of Chemistry, Manufacturing, and Controls (CMC) requirements is essential for successful drug development. We offer thorough CMC regulatory support, backed by extensive industry experience (over 150 years in total) and a proven history of success (see testimonial page). Our specialists assist you through every stage of CMC development, from formulating robust CMC strategies to achieving marketing authorization.

We provide customized solutions to suit your unique requirements, whether you need ad-hoc services, help with specific projects, or a completely outsourced team.

What can we do for you?

Our CMC regulatory consultants have extensive experience and expertise to support you through all stages of CMC development and the regulatory approval process.

We specialize in regulatory consultancy support during the development and registration of:

  • Small molecules (including generics)
  • Biologics (including biosimilars)
  • Vaccines
  • Advanced therapy medicinal products (ATMPs), including cellular and gene therapy products

Partnering with us can help your regulatory submissions and accelerate your journey from development to market. Our goal is to ensure your products reach patients safely and efficiently. 

When required for your project, we can provide a collaborative approach to ensure seamless integration with other disciplines, including non-clinical, clinical, and regulatory. This comprehensive support guarantees that your CMC program is fully aligned with overall development and regulatory strategies.

Jolanda Lamers-Lemmers
Management team member - Senior RA Manager

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Jolanda Lamers-Lemmers
Management team member - Senior RA Manager

Let's Connect

Talk to an expert