Active Substance Master File (ASMF) Submissions

Active Substance Master File (ASMF) Submissions

Active Substance Master File (ASMF) is a confidential document containing detailed information about the quality and manufacturing of an Active Pharmaceutical Ingredient (API). It is also referred to as Drug Master File (DMF) in some regions. The ASMF submission is not a mandatory requirement from the EU Health Authorities. However, it is advisable to submit an ASMF to avoid administrative comments/rejections of Marketing Authorization Application (MAA). Which is due to non-availability of the ASMF and to receive timely MAA approval.

ASMF Submission Process

Possesses significant expertise in managing the life cycle of ASMF submissions. This includes submitting the document to the EU Health Authorities according to the MAA holder’s identified submission procedure. Additionally, the ASMF holder may issue an LoA to multiple MAA holders, which can serve as a reference in various applications.

Importance of ASMF Submission

Offers end-to-end Regulatory support for ASMF submissions, starting from the preparation of the ASMF dossier, submission to the EU Health Authorities, and ongoing life cycle management. Their team of experts provides comprehensive support in terms of data collection, dossier preparation, scientific and technical writing. Which also include the necessary documentation for submission.

Multiple MAA Holders

We also provides regulatory consulting services to clients to help them navigate the regulatory landscape and understand the specific requirements related to ASMF submissions. They can provide guidance on documentation requirements, timelines, and necessary updates and changes throughout the lifecycle of the ASMF.

Additionally, Templarpharma ensures timely updates and changes to the ASMF dossier, as per the regulatory requirements. Which maintain compliance and avoid delays in the MAA approval process. Templarpharma’s team of experts can assist with handling variations to the ASMF, including Type I, II, and III variations, to ensure that the dossier is up-to-date with the latest regulatory guidelines and requirements.

End-to-End Regulatory Support

In summary, Templarpharma has extensive experience and expertise in handling ASMF submissions and their life cycle management. Their end-to-end Regulatory support for ASMF submissions. Combined with their regulatory consulting services, ensures that clients are well-equipped to navigate the regulatory landscape and achieve timely MAA approvals for their products.

Expertise in Active Substance Master File

  • Assistance in identifying the appropriate Regulatory starting material and intermediates for manufacturing active pharmaceutical ingredients (APIs).
  • Guidance on selecting the most suitable route of synthesis for APIs.
  • Support in designing acceptable limits for impurities in starting materials, intermediates, and their carry-over to APIs.
  • Designing specifications for starting materials, in-process, intermediates, and active substances.
  • Assistance in setting the control strategy and limits for genotoxic impurities and elemental impurities in intermediates or active substances.
  • Provide advice on developing protocols for conducting stability studies, process validation, hold time studies, and forced degradation studies in preparation for ASMF submission.
  • Reviewing manufacturing details of starting materials for adequacy in ASMF.
  • Preparing, reviewing, and submitting ASMFs to avoid any delays in approval.
  • Publishing ASMFs in the eCTD format as per the current EU guidelines.
  • Providing regulatory strategy, preparation, and submission of variations for already registered ASMFs.
  • Providing regulatory strategy, preparation, and submission of renewals for already registered ASMFs.
  • Providing regulatory support for ASMFs in response to Health Authority queries.
  • Advising on compliance with regulatory requirements for ASMFs.
  • Assisting in identifying and mitigating potential quality issues in starting materials, intermediates, or active substances.
  • Reviewing and providing feedback on analytical methods used for testing starting materials and intermediates.
  • Evaluating the suitability of analytical methods for detecting impurities in starting materials and intermediates.
  • Assessing the risk associated with the use of starting materials or intermediates in API manufacturing.
  • Reviewing and providing feedback on the documentation required for ASMF submission.
  • Providing guidance on the regulatory requirements for manufacturing starting materials and intermediates.
  • Offering support and advice on other aspects of API manufacturing, such as process optimization and risk management.