Chemistry, Manufacturing, and Controls (CMC)

Ergomed’s CMC services are guided by our expert regulatory teams, who navigate the complex regulatory landscape and ensure the success of your product development. Particularly in Cell and Gene Therapies (CGT), our teams provide comprehensive guidance on assessing CMC readiness against regulatory standards, International Conference on Harmonization (ICH) guidelines, and monographs.

We offer expertise in various areas, including:

• Control of materials
• Manufacturing process development
• Potency assays and potency assurance
• Analytical procedures and control strategy
• Stability protocols
• Current Good Manufacturing Practices (cGMP) requirements

By crafting tailored strategic development plans and interpreting scientific results, we help define critical quality attributes and establish robust control and stability strategies. Our support extends to preparing and submitting dossiers for clinical trial submissions or authorizations, ensuring effective engagement with regulatory agencies, and maintaining compliance throughout the product lifecycle.

Our CMC regulatory expert teams offer detailed assessments of your CMC readiness against regulatory guidance, ICH guidelines, and monographs. Our services include technical evaluations of your body of data on materials, manufacturing processes, and their development, as well as analytical procedures and control strategies. We advise on compliance with cGMP requirements, stability testing, and shelf-life establishment. Additionally, we provide tailored regulatory strategy, expert guidance, scientific interpretation, documentation assistance, ongoing support, global regulatory support, and customized solutions.

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