Ergomed Chemistry, Manufacturing, and Controls (CMC):

CMC Regulatory Guidance:

The CMC regulatory expert teams, particularly in the area of ATMP/CGT, can assist in assessing your CMC readiness against regulatory guidance, ICH guidelines, and monographs in the following areas:

  • Components used in product manufacture (e.g., raw materials)
  • Manufacturing process including development, changes, and comparability
  • Potency assay and potency assurance
  • Analytical procedures (qualification and validation)
  • Specifications (control strategy)
  • Current Good Manufacturing Practices (cGMPs) requirements
  • Stability

 

CMC Regulatory Services:

  1. CMC Regulatory Strategy:

    • Crafting tailored strategic development plan to ensure compliance and success.
    • Providing guidance on navigating regulatory landscapes and addressing challenges proactively.
    • Interpreting scientific results to support control and stability strategies (e.g. defining critical quality attributes and associated specifications, and stability plan and product shelf-life establishment).
  1. CMC Documentation Preparation for Clinical Trial Submission or Authorization:

    • Supporting engagement with regulatory agencies for effective communication and advice (e.g. Scientific advice/Briefing Book Preparation)
    • Assisting in the preparation, review, publication, and submission of electronic common technical document (eCTD) applications (e.g., Investigational new drug (IND), Clinical trial authorization (CTA), Investigational medicinal product dossier (IMPD),New drug application (NDA), Biological Licence Authorization (BLA) , and Marketing authorization application (MAA))
  1. Maintenance of Clinical Trials or Authorizations:

    • Offering ongoing support for the maintenance of clinical trials or authorizations (e.g. modification and variations).
    • Ensuring continued compliance and success throughout the product lifecycle.

 

CMC global support

  • Including global considerations in the product development strategy.
  • Accounting for variations in local regulations.
  • Addressing supply chain & logistics complexities.
  • Managing global clinical trial submissions.
  • Preparing and submitting Genetically Modified Organism (GMO) dossiers.

 

Customized solution

  • Providing full regulatory affairs support including medical writing (insert link).
  • Offering in-house or access to preclinical toxicologists and pharmacokineticists.
  • Offering in-house or access to clinical therapeutic area experts.

 

Ergomed, coupled with PrimeVigilance capabilities, presents a comprehensive one-stop solution for the seamless clinical development and global authorization of your product. Partnering with us ensures a streamlined pathway from development to authorization, providing peace of mind and efficient navigation through regulatory landscapes worldwide.

 

Publications and Webinars

“Navigating GMO Landscape following the EU Clinical Trial Regulation 536/2014 implementation”

Writing an IND Module 3 for Cell and Gene Therapy Products: Considerations and Challenges

Regulatory Dashboard | GMO Regulatory Considerations for Advanced Therapies in Europe

Regulatory Dashboard | Regulatory Frameworks for Advanced Therapies