R&D Development Support, CMC (Chemistry Manufacturing and Control), Regulatory Compliance for Drug Substance and Drug Product Registration

Evobiotix team can help companies to develop research and development programs from the earliest to the most advanced stages, thanks to the solid know how in naturally-derived, biologically active molecules and in small molecules.

Our activities encompass strategic intelligence and assistance through the whole R&D process, with a high focus on costs analysis.

Evobiotix offers design and supervision of CMC-oriented activities in order to implement effective product development and cope with the regulatory requirements, thus guaranteeing quality and compliance throughout the entire product life cycle.

Part of the assistance program that Evobiotix can put in place in the framework of the CMC duties includes the evaluation of Technical Agreements with third parties such as CMOs (Contract Manufacturing Organisations) and Quality Agreements between Parties.

Technology transfer support, finished product formulation expertise and Quality Assurance activities on demand (such as performing Annual Product Review, providing advice on Process Validation and preparation of quality documentation like Standard Operating Procedures and Policies)

Upon request Evobiotix also performs analyses on current processes, takes care of process optimization, scale-up and development of analytical methods both on drug substance and drug product.

Tailor-made design of protein isolation and purification, as well as development of the related analytical methods is an Evobiotix plus, thanks to the extensive experience and professional backgrounds in Biochemistry and Biopharmaceuticals.