Chemistry, Manufacturing, and Controls (CMC)

Our expertise span across a wide range of products including:

• Small Molecule Drugs
• Biologics: Antibodies, Recombinant Proteins, Vaccines, Biosimilars and others.
• Advanced Therapies: Cell Therapies & Gene Therapies with several delivery methods such as Viral Vectors (Adeno-Associated Virus [AAV], Lentivirus, and Retrovirus) and Non-Viral vectors (lipid nanoparticles, naked DNA, and plasmid vectors).

Our CMC regulatory team, comprising of seasoned professionals with decades of experience, who navigate the complex regulatory landscape and ensure the success of your product development.

We offer expertise in various areas, including:

• Control of materials
• Manufacturing process development
• Potency assays and potency assurance
• Analytical procedures and control strategy
• Stability requirements
• 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. This includes offering guidance during regulatory agencies’ engagement (e.g., Pre-IND, EMA and National Scientific Advice) and developing briefing packages. Our team is experienced in preparing, reviewing, publishing, and submitting applications in the electronic common technical document (eCTD) format for submissions such as such as 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). We also prepare and submit Genetically Modified Organism (GMO) dossiers for Contained Use/Deliberate Release requests within the EU.

Our CMC regulatory expert teams offer detailed assessments of your CMC readiness against regulatory guidance. Our services include technical evaluations of your body of data and technical/scientific ongoing support. Additionally, we provide tailored expert guidance, documentation assistance, 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.