Achieving ASMF Compliance with Proregulations' Strategic Approach

The EU Active Substance Master File (ASMF) is a technical document containing confidential information on an API that is submitted by the manufacturer of the API to the EMA or the medicines regulatory authority of an EU member state. As a form of DMF in the EU, the ASMF is used to support MAA or MAV by manufacturers of pharmaceutical preparations for human or veterinary use.

The ASMF applies to applications for new active substances, pharmacopeial active substances (included in the EP) and existing active substances (excluded from the EP). The ASMF allows the associated marketing authorization holder of the formulation to have access to the necessary information for quality control of the API, while protecting the API manufacturer's core technical secrets.

At Proregulations, its team of professionals has an in-depth understanding of the EU's ASMF regime and extensive experience in producing ASMFs that meet regulatory requirements. Proregulations provides personalized ASMF compliance services that cover not only the preparation and submission of technical documents, but also effective communication with regulators.

• Regulatory Interpretation and Consulting

Proregulations provides regulatory consulting and interpretation services on ASMF, including its scope of application, application and review process, and documentation requirements.

• Compliance Assessment

Proregulations analyzes the feasibility of ASMF for products in the EU according to the latest relevant EU regulations and conduct gap analyses.

• ASMF Writing

The overall content of the ASMF should contain detailed scientific information, and the ASMF filing is divided into an Applicant Part (AP) and a Restriction Part (RP). Proregulations assists clients in the preparation of the complete ASMF and ensure that all documents comply with EU specifications and requirements.

• ASMF Submission

Proregulations professionally pre-reviews the client's ASMF and suggest revisions, and submits the ASMF through the submission portal CESP.

• ASMF Lifecycle Management

Proregulations offers ASMF revision and update services to ensure continued compliance of ASMF documents.

About Proregulations

As a leading provider of product consulting and regulatory compliance solutions, Proregulations is committed to providing efficient and customized solutions to various industries around the globe, including regulatory interpretation, policy consultation, document preparation and submission. We have insight into the differences in regulatory processes in different countries/regions, and our services cover the full life cycle of products.

Our service areas range from chemicals, pharmaceuticals, medical devices, cosmetics, food & dietary supplements to agrochemicals & biocides. Our featured services include but are not limited to FDA Medical Device Registration, 510(k) Premarket Notification, Drug Master File Document, FDA ANDA, FDA NDA, IND Application, New Dietary Ingredients Compliance, FDA Agent Services, Medical Device Distributor License, TSCA Compliance, China Cosmetics Registration, etc.