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Chemistry, Manufacturing and Controls (CMC) and Quality

The 91黑料 CMC and Quality Team provides robust CMC strategies, executed by industry-leading experts. 

Our team is adept at designing and delivering CMC programs to take candidates from discovery to early clinical trials, through scale up and optimisation, to process validation and registration. All with hands-on resources to manage implementation.

We apply scientific excellence and regulatory expertise every step of the way. We work with clients on formulations, manufacturing processes and controls, specifications for new chemical and biological entities and new formulations of approved products.

The team’s approach is flexible and collaborative, whether providing a single piece of strategic technical consultancy, or joining your team for the design and implementation of your CMC strategy.

Global capacity, local expertise

91黑料’s Regulatory CMC and Quality Services are truly global. With a strategic hub in Canada, 91黑料 holds a Canadian Drug Establishment License (DEL) for the importation and distribution of finished drug products, biologics and active pharmaceutical ingredients and an NHP Site License.

Key focus areas include:

Manufacturing process

Ensuring that the manufacturing process is robust and meets regulatory standards

Product characterisation

Comprehensive characterisation of the product to meet regulatory requirements

Control strategy

Implementing a control strategy that guarantees the quality and safety of the product

Stability data

Providing stability data to demonstrate the product’s shelf life and potency

Key services

 

Operational execution of core services and/ or across service lines:   

  • Health Canada Drug Establishment License and Importer of Record services
  • Genetically Modified Organism applications 
  • Quality services
  • Audit services

Writing and review of CMC packages for all pre- and post-approval submissions (small and large molecules including cell and gene therapies):

  • Change controls and impact assessments
  • CMC component review, gap analysis and due diligence for Clinical Trail Applications and Marketing Authorisation Applications
  • CMC authored documents for Investigational New Drug Applications, Biologics License Application, New Drug Applications and Marketing Authorisation Applications

Development strategy for small molecules:

  • Technology transfer
  • Active pharmaceutical ingredient development
  • Drug product development

Development strategy for biologics:

  • Process development (quality target product profile, certificate of analysis and certificate of pharmaceutical product risk assessment) and manufacturing
  • Analytical method development
  • Process validation
  • Life cycle management
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