Regulatory Medical Writing
Whenever the term bioequivalence is mentioned, many of us think of the BE study and all the importance is always given to the clinical activities. However, a much-focused attention is also needed on the analysis of the data from the studies. In addition, in depth literature research is must for the right interpretation of the results, which leads to the perfect synopsis of all your hard work. For complicated projects before making large investments it is beneficial to ask relevant regulatory authorities for a scientific advice. Controlled correspondence is an effective way to make requests, submit changes and deliver specific information to regulators. A strict adherence to guidance’s while writing scientific discussions / write ups or controlled correspondences increases chances of acceptance and one can expect a speedy response from regulatory to your questions which will help you in designing and planning biostudies.
Through Mediblog we support the generic pharmaceutical companies on the precise need of analysing, presenting the BE study related data and writing the conclusions in globally accepted formats. With complete understanding of the various guidelines dictating the Bioequivalence and its presentation, Pharmadesk has been successfully providing literature support to multinational generic players. Pharmadesk has experience of writing scientific discussions / write ups and controlled correspondences to regulators. Our expert can understand your queries thoroughly and draft those into a scientific language with proper rationale as per the recommended guidance for respective regulatory agency to ensure getting a required details / desired information. With years of experience in supporting generic dossier submissions with USFDA, MHRA, TGA, Health Canada & other regulated agencies, Pharmadesk has developed an unmatched skillset of compiling the data for a perfect regulatory review. A dedicated team at Pharmadesk is focused on compiling, writing, and organizing the relevant study data.
We need assistance in writing controlled correspondence to USFDA or EMEA
We need technical experts for writing Clinical, Nonclinical & Bibliographic review.
| Services |
|
||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|||||||||||||||||||||
Our business development team will contact you and arrange telecon.
