CMC regulatory services

CMC regulatory services

We have long-standing regulatory knowledge and provide a comprehensive range of CMC writing services to streamline your application while taking a phase-appropriate approach.

Integrated. Proven. The smartest path to your clinical milestones.

CMC documentation and innovations developed side-by-side

The assessment of a drug application by regulatory agencies is a complex process that involves multiple stakeholders. For some companies, Chemistry, Manufacturing and Control (CMC) writing and dossier compilation can be a resource-intensive and costly process that can delay or even derail the drug development process.

Our regulatory CMC team has expertise in all areas of product development from small molecules to oligonucleotides over nanomedicines to biologics such as vaccines, monoclonal antibodies, and peptides. We also have a deep understanding of the regulations for drug substances, pharmaceutical excipients, packaging materials and drug-device combination products.

Our approach means you stay ahead of the game when it comes to advancing products to the clinic, accelerating the journey and enabling greater adaptability and flexibility in your project.

From early development through manufacturing, we provide regulatory advice and compile your application by using phase-appropriate standards.

JUMP TO:

Scientific Report Writing

Scientific Report Writing

We are experts in writing scientific and technical reports using a dossier-centric approach. This means we keep the final application in mind throughout to ensure consistency, completeness and readability.

 

Examples of scientific report writing services include:

Drug product

  • Drug product formulation development reports
  • Drug product manufacturing process development reports
  • Investigation reports
  • Criticality analysis reports
  • Technology Transfer reports

Drug substance

  • Mutagenicity assessment reports
  • Nitrosamine risk assessment reports
  • Criticality analysis reports
  • Origin and fate of impurities during the drug substance process
  • Regulatory starting material justification reports
  • Process development reports
  • Proven Acceptable Ranges (PAR) justification reports

Analytical development

  • Stability reports
  • Dissolution reports
  • Microbiology reports

Module 3 Writing

Module 3 Writing

We understand that a consistent and compliant regulatory dossier is the key to obtaining timely clinical trial approval and smooth marketing authorization. However, the path to approval may be burdensome. That’s where our CMC regulatory services team comes in, helping you to accelerate the drug approval process.

For more than 25 years we have focused on (CMC) and can offer you in-depth knowledge, insight and unparalleled experience.

Our writing services

  • Module 3 and 2.3 quality sections for IMPD, IND and full MA or NDA
  • Expertise to adapt the level of detail according to all development phases (1-4)
  • Ability to cover all territories (FDA, EMA, Canada, Japan, Brazil, ROW)
  • Electronic common technical document (eCTD) compilation

Regulatory CMC support

Regulatory CMC support

We have comprehensive experience complying with regulations in all major regulated markets, including the US and Europe.

Maintaining compliance with new legislation and guidelines can be a resource-intensive challenge for pharmaceutical companies and is a key area where we can help. Our team supports you by assessing and interpreting regulatory documents on your behalf. Based on case-by-case assessments of the procedures or principles already in place at your facilities, we assist you with the implementation of new legislation to ensure you achieve compliance.

Our regulatory CMC support services

  • Strategic advice
  • Justification of specifications
  • Design of stability studies
  • Addressing specific CMC questions during development and Health Authority questions
  • Briefing Books for scientific advice
  • Gap analysis
  • Filing and registration strategy
  • Variations and Renewals
  • Full life cycle management of MA

Related resources

Our experts share their deep, scientific understanding and insights into the regulatory environment and CMC writing.

See all resources
On-demand webinar: Compatibility and In-Use Stability Studies for Injectables
Webinars

On-demand webinar: Compatibility and In-Use Stability Studies for Injectables

Read more
# CMC Regulatory Drug Product Injectable Drugs
On-demand webinar: Navigating CMC requirements for Spray Drying Processes
Webinars

On-demand webinar: Navigating CMC requirements for Spray Drying Processes

Read more
# Bioavailability Enhancement CMC Regulatory
Scientific/CMC Writing and Regulatory Support
Info sheets

Scientific/CMC Writing and Regulatory Support

Read more
# CMC Regulatory
Navigating the CMC Regulatory Landscape for Oligonucleotide Therapeutics
Info sheets

Navigating the CMC Regulatory Landscape for Oligonucleotide Therapeutics

Read more
# CMC Regulatory Nanomedicine
Leverage the power of CMC in early drug development
Whitepapers

Leverage the power of CMC in early drug development

Read more
# CMC Regulatory Drug Product Drug Substance
Much more than just smoke - from marijuana to medicinal cannabis derived therapeutics
Whitepapers

Much more than just smoke - from marijuana to medicinal cannabis derived therapeutics

Read more
# CMC Regulatory Drug Product Drug Substance
Scientific Advice and Dialogue with EMA during Drug Development
Whitepapers

Scientific Advice and Dialogue with EMA during Drug Development

Read more
# CMC Regulatory

Your molecule, your journey, our mission.

Get in touch to see how we can craft your path to the clinic with dedicated capabilities.

Get in touch

Our integrated platforms

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.

Drug substance

Helping you turn your compounds that show promise into GMP-grade drug substances.

Drug product

We advance your clinical candidates through the pipeline quickly and safely with specialist drug product services.

Bioanalysis

Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline preparation and submission of your registration file.

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.

Drug product

We advance your large molecule candidates through the pipeline quickly and safely with specialist drug product services.

Bioanalysis

Our bioanalytical platform supports your large molecule drugs through preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your large molecule drug.

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.

Drug product

We turn your nanomedicine candidates into suitable drugs with specialist development and manufacturing services.

Bioanalysis

Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your nanomedicines.