ECC Services: Biotech Startups
Providing All the Know-how
ECC (Estermann Chemical Consulting) will provide your biotech startup, in perfect alignment with your needs and requirements, with all the knowledge necessary to ensure pharmaceutical quality throughout your manufacturing process, in order to guarantee the physical and chemical properties and consistency of your pharmaceutical products, right from the outset. Our consultancy and support services run the gamut, all the way to assuming the supervision of the entire CMC package, including:
The evaluation of the synthesis route
The evaluation of potential CDMOs based on the work package
The preparation of the requests for proposals and inquiry of the CDMOs
The evaluation and ranking of the offers
The supervision of the work at the CDMO
Route scouting
Route selection for development
Process development, taking into account clinical phase, quality, quantity, costs, safety, and the environment
Production of the active pharmaceutical ingredient/API taking into account safety, environment, quality, quantity, and costs
Documentation review (synthesis procedures, analytical procedures, master batch records, executed batch records, safety documents, etc.) on completeness, properness and compliance
Registration documentation review or preparation
Continuous evaluation of the processes with respect to safety, scalability, robustness, quality, yield, compliance, and costs
Also, we will gladly draw on our more than three decades of industry experience to render advice on the appropriate course of action during sales negotiations with “Big Pharma” companies.