A Master File is a type of document submitted to Health Canada to provide important information about an API, finished dosage form, excipients and container closure systems, and processes used in the manufacturing, processing, packaging and storing of human drugs. It is submitted to support drug application. Submission of Master Files is not mandatory however, manufacturers can submit the DMF to maintain the confidentiality of proprietary information for the holder.
The information submitted in the Master File can only be accessed by Health Canada if the Master File holder provides a Letter of Access (LOA) to the applicant and Health Canada. Additionally, the DMF holders can also submit the copy of Certificates of Suitability (CEP) for quicker review and acceptance of Master File.
Freyr has a Regulatory team with in-depth understanding and experience in handling the Master file registration activities in eCTD format, along with managing and updating the MFs, in alignment with the latest guidelines by Health Canada.
Serve as a Canada Agent between the Agency and the manufacturer for interactions with Health Canada
Regulatory submission strategy for different types of Master Files (MFs) for drug substance (Type I), packaging materials (Type II) and Excipients (Type III)
Guidance on selection of Regulatory starting material and route of synthesis for Drug Substance in line with HC expectations
Support in designing the limits for impurities in starting materials, intermediates and their carry over to Active Pharmaceutical Ingredients (APIs)
Designing of specifications for starting materials, in-process, intermediates and drug substance
Support in setting the strategy and limits for genotoxic impurities and elemental impurities in intermediates or drug substance
Guidance on designing the protocols for stability studies, process validation, hold time study and forced degradation studies for MF submission
Preparation and submission of Type I/II/III Master Files in line with Health Canada requirements
Publishing of MFs in eCTD format as per current HC guidelines and requirements
Change control evaluation and Regulatory strategy, preparation and submission of amendments and annual reports for already registered Master Files
Regulatory strategy, preparation and submission of the response to Health Authority queries
Conversion of existing paper/non-CTD MFs into eCTD format