Compliance with regulatory guidelines is mandatory for drugs and vaccines meant for human use but these guidelines may vary from country to country. In order to ensure that our clients can confidently use their products in clinical trials; we provide the regulatory support and expertise for the submission and maintenance of regulatory filings, according to various governmental entities such as the EMA, the FDA and the AIFA.
Advent’s Regulatory Support team can assist our clients with drafting and submitting multiple documents, such as:
- The IMPD (Investigational Medicinal Product Dossier), one of several pieces of Investigational Medicinal Product (IMP) related data required whenever the performance of a clinical trial is intended in one or more European Union Member States. The IMPD includes summaries of information related to the quality, manufacture and control of any IMP (including reference product and placebo), and data from non-clinical and clinical studies;
- The IB (Investigator’s Brochure), a compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects;
- The CMC section of the Investigational New Drug (IND) application with information describing the composition, manufacture, and control of the investigational drug substance and the investigational drug product.
In addition, our team can also provide support for pre-submission meetings, procedure preparation and submission. Due to our experience and extensive know-how of procedures in various countries, our team can support your regulatory filing by understanding the questions of the agency and preparing adequate responses.