EU Active Substance Master File (ASMF) Production


Background of the EU Active Substance Master File (ASMF)

EU Active Substance Master File (ASMF) Production

The ASMF, also commonly referred to as the European Drug Master File (EDMF), is a confidential document that contains detailed information on the manufacturing process, characterization, and quality control of an active substance (also known as an API or drug substance). The ASMF is submitted to the regulatory authority by the manufacturer of the active substance and can be referenced in regulatory submissions of drug product manufacturers who use the active substance in their products. ASMF provides the EU health authorities with all the necessary information to evaluate the suitability of the substance for use in the product. It also allows the marketing authorization holder of the drug product to take responsibility for the quality of the active substance used. This helps ensure that the product meets the necessary standards for safety and efficacy.

About Us

Our team of experts offers a range of ASMF production services to help our clients cope with the complex regulatory environment in the European Union.

We offer a range of services related to regulatory affairs, quality assurance, and pharmacovigilance for the pharmaceutical industry, including the preparation of ASMFs. Our team of highly experienced professionals has a deep understanding of the regulatory requirements for ASMFs in the EU and can assist our clients in preparing accurate and complete ASMFs that meet all regulatory requirements. We work with regulatory authorities to address any questions or concerns that may arise during the review process. We offer several advantages to our clients, including extensive experience, quality assurance, and personalized service. As a leading provider of regulatory compliance services for the pharmaceutical industry, we are committed to ensuring the highest level of quality in all of our services and providing ongoing support to our clients throughout the ASMF preparation process.

ASMF Usage

We help customers submit ASMFs for use in support of a Marketing Authorization Application (MAA) or Marketing Authorization Variation (MAV). Our ASMF production services are available for the following active substances:

  • New active substances
  • Pharmacopeial active substances, included in the (Ph. Eur.)
  • Existing active substances, which are excluded from the European Pharmacopoeia (Ph. Eur.)

Our ASMF Production Services

We guide the complete process and documentation required for ASMF filing and review. Following are our company's services:

  • ASMF writing and submission services
    • ASMF audit
    • ASMF conversion from paper/CTD to eCTD
    • Module writing for the applicant part (AP) and restricted part (RP) of ASMF for API, intermediate, and semi-finished dosage forms.
    • Assist in submitting ASMF to EU health authorities through the submission portal CESP
    • Assistance in response to additional information requests
    • Query response assistance while reviewing when referenced to MAA application
  • eCTD publishing services
    • eCTD compilation, QC review, and technical validation
    • eCTD publishing for original ASMF for API, Intermediate, and formulation
    • eCTD lifecycle management
    • Any changes to the existing ASMF revision filing
  • Life-cycle management of ASMF
    • ASMF revision preparation and eCTD publishing
    • Query response to support amendment filing for safe approval
    • Revising and updating ASMF

Our Advantages

  • Extensive experience
    Our team of professionals has many years of experience in the pharmaceutical industry, and we have prepared numerous ASMFs for our clients.
  • Quality assurance
    We have established a comprehensive quality management system that includes standard operating procedures, quality control measures, and regular training for our staff.
  • Personalized service
    We work closely with our clients to provide personalized service that meets their specific needs.

If you need help or have a question, please feel free to contact us for more details.

Contact Us

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