Accurate planning. use of correct BE study design, samples size estimation and close monitoring
are key to successful BE Study. Pharmadesk is an expert in BE studies and a market leader in giving
the most appropriate advice in this area.
Our medical writing team comprises of clinicians and pharmacologists and provide a full range of medical report
writing services. The medical writers have experience in write-ups to prepare technically sound documents that
are compliant with applicable regulatory guidelines and have proven track record for their acceptance in EMEA, MHRA and USFDA submissions.
Do you face challenges in validating the technical data of Biostudies, Formulation or Contract Manufacturing data?
What about reviewing the dossiers data to decide if it meets your regulatory requirement to
descide go no go before inlicensing the dossier?
Accurate planning. use of correct BE study design, samples size estimation and close monitoring are key to successful BE Study.
Our medical writing team comprised of clinicians and pharmacologists, provides a full range of medical report writing services.
Do u face challenges in validating the technical data of Biostudies, Formulation or Contract Manfacturing data?
