Regulatory Medical Writing
Aquila’s SMEs are able to assist you with the preparation of high quality regulatory documentation to support your development activities.
Regulatory documents are a distillation of the time, effort and money you have invested to obtain your data. A poorly written and presented document fails to do justice to your work, and can result in unnecessary questions and confusion.
And it’s not only regulators who are influenced by the quality of your regulatory documentation; investors, partners and licensees will perform rigorous reviews before they enter into a deal. The authoring of regulatory documentation is a skilled job demanding accuracy and creativity in order to identify, extract and clearly present the required level of detail appropriate to fulfill the objective of the document concerned.
Aquila’s SMEs leverage many years of regulatory and medical authoring experience together with an in-depth understanding of the required content of each regulatory document based on the stage of development and type of product
Common Authoring Projects
– Investigational Medicinal Product Dossiers
– Clinical Overviews and Summaries
– Quality Overall Summaries
– CTD Module 3
– Scientific Advice Briefing Books
– Orphan Drug Applications
– Paediatric Investigational Plans
– Environmental Risk Assessments