Regulatory support for viral vaccine products
Advaxia streamlines the CMC process from drafting to filing during the clinical phases of development.
Compliance with regulatory guidelines is mandatory for every drug intended for human use. Advaxia’s team of regulatory specialists provide support throughout every stage of the clinical regulatory process, from drafting documents, to filing investigational submissions.
We possess years of experience in dealing with governmental entities such as the EMA, the FDA and the AIFA, as well as numerous local and regional regulatory bodies around the world. Let us put our regulatory expertise to work for you.
Advaxia’s regulatory support team is ready to help with drafting and submission of documents for clinical trial applications such as the following:
The Investigational Medicinal Product Dossier (IMPD)
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), along with data from non-clinical and clinical studies.
The Investigator’s Brochure (IB)
This compilation of the clinical and nonclinical data on the investigational product(s) is required in many regulatory filings related to the study of the investigational product(s) in human subjects.
The CMC section of the Investigational New Drug (IND) application
This section must provide information describing the composition, manufacture, and control of the investigational drug substance and the investigational drug product.
Our team also specializes in providing support for pre-submission meetings, as well as procedure preparation and submission. Leverage our experience and extensive know-how of regulatory procedures countries around the globe, so you can move forward on your clinical trial with confidence and peace of mind.