Regulatory Affairs
Our team of Regulatory Affairs experts plays a pivotal role in your project from start to finish. In addition to compliance with applicable laws and guidelines, they scrutinize the appropriate licensing and legal compliance of pharmaceutical and medical products, thereby ensuring the quality, safety and efficacy of products.
As an integrated supplier, we combine our knowledge of scientific, legal and business issues to ensure that products which are developed, manufactured or distributed by a wide range of companies, fully meet the expectations of regulators worldwide. A combination of expertise and passion for regulatory excellence means that with Siegfried you can expect more.
We advise on and coordinate the approval and registration of pharmaceuticals and chemicals, therapeutic devices and other products.
Regulatory affairs officers are a crucial link between your company, your products and regulatory authorities, including the Medicines and Healthcare products Regulatory Agency (MHRA), the US Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and other national regulatory bodies.
Our Range of Services
In addition to our consulting activity, we prepare and deliver the necessary approval documentation for actives and medicinal products "ready-to-file" for submission in paper-CTD, electronic (NEES) or in eCTD formats:
- Drug Master Files for the EU, USA, Japan as well as other worldwide markets
- Quality documentation (Modules 3.2.S, 3.2.P) for IND or CTA submissions
- Complete CMC portions (Module 3.2.S) for approval applications
- EP-Certificates of Suitability (CEP)
- Complete registration documents (Modules 2-5) for the authorization process of generic pharmaceuticals
- Notifications of change
The conditions vary with each project and depend on the scope of the requested supplementary services. For the authorization of medicinal products in Europe, we are able to handle the complete regulatory process as an applicant.