A Drug Master File (DMF) is a submission to regulatory agencies, that contains critical information about the chemistry, manufacturing, and control (CMC) aspects of a pharmaceutical product or active pharmaceutical ingredient (API). DMFs are an essential resource for the regulatory process, as they provide detailed insights into the facilities and processes used in the production, processing, packaging, and storage of drugs that can be referenced by pharmaceutical companies who wish to seek product approval.

Regulatory intelligence is the systematic gathering, analysis, and interpretation of regulatory information that supports informed decision making and compliance with regulatory requirements. It involves monitoring and staying updated with changes in the regulatory environment including guidelines and trends that may impact a specific industry or product category. Indeed, Regulatory Intelligence encompasses the study of existing regulations as well as the anticipation of future developments that might affect a pharmaceutical organization’s product filing strategy.

A Letter of authorisation (LoA) is a formal document that gives permission or authority to a third party to act on behalf of another party. It provides formal permission or consent granted by one party to another and the authorization is typically granted within the context of regulatory submissions and interactions with regulatory authorities.

An IMPD, or Investigational Medicinal Product Dossier, is a crucial document in the process of developing new pharmaceutical products. It serves as a comprehensive and structured compilation of all relevant data and information about the investigational medicinal product (IMP) being studied in clinical trials. IMPDs play a vital role in ensuring the safety, quality, and efficacy of medicinal products before they can be approved for marketing and distribution to patients.