Regulatory Assistance

We guarantee our customers fast and reliable technical and regulatory assistance.
Our regulatory affairs team is at your disposal and provides both support and documentation useful in your regulatory processes.

Regulatory support service:

Full consultation about our production processes and product use, equipment and products regulatory classification.
Support throughout your regulatory registration process including response to health authorities’ requests e.g. justifications, risk-analysis, supportive data (TSE/BSE-; latex-free statement)
Prepare documentation of compliance with applicable regulations
Write and compile a regulatory documentation such as ASMF (EU)/DMF (US FDA) according to eCTD format requirements
Prepare the regulatory documentation for publishing and submission via FDA Electronic Submission Gateway/ or the Common European Submission Portal (CESP) from the Heads of Medicines Agencies (HMA)

Drug Master Files (DMF) and documentation at your disposal upon request:

Helping you with your regulatory procedures also means compiling essential documents. To do this, our regulatory department has a set of documents such as the Drug Master Files (DMF) that allow you to meet regulatory requirements regardless of the competent authority (EMEA or FDA).

Please don’t hesitate to get in touch if you would like more information about our quality control or regulatory support.

Regulatory Affairs