Biopharma

Eurofins Regulatory and Consultancy Services Italy supports pharmaceutical drugs company to select the right path to guarantee safety and quality. Our team helps to deal with regulatory challenge leveraging on a science- and risk-based approach. Our experience in diverse manufacturing and regulatory settings (from small molecule to biologics and ATMPs) ensure our clients needs are fully understood and easily transformed in solid strategies.

Our teams of experts in the pharmaceutical field support industries in different phases of the drug product development process.

Safety and quality need to be ensured since the very beginning of the product life-cycle.

Here is where our toxicology experts support our Client, for example through the characterization of any kind of unwanted impurity.

Moving towards commercial manufacturing, our validation experts take in charge the planning of qualification of facility through the final steps of process and cleaning validation. Our support is also granted when validation needs to be maintained, through statistical process control and process capability evaluation.