Medical Writing

The success of your programs are dependent on high quality documents delivered on-time

 

The importance of having the right level of subject matter expertise, depth of writing capabilities and effective project management oversight, is critical for quality and compliant medical writing. Sciformix provides a full range of medical writing services spanning the spectrum of drug development from pre-clinical to clinical through post marketing activities. We offer standalone and comprehensive end-to-end medical writing service.

– Clinical Writing
– Regulatory Writing
– Medical Information & Communications
– Aggregate Reporting

 

Dr. Chitra Lele, Chief Scientific Officer, Sciformix

Quality Management Systems (QMS) for Safety and Risk Management – A Regulatory Requirement Or A Business Need?


Dr. Chitra Lele Ph.D.

[This post is the first part in a series that will focus on achieving operational excellence with an effective quality management system.] The role of pharmacovigilance or product vigilance (PV) has changed from a regulatory and legal imperative for capturing and reporting...

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More Oversight Of AEDs Proposed By FDA


Susan Najjar

A proposal to improve the quality and reliability of automated external defibrillators (AEDs) has been issued by the U.S. Food and Drug Administration.  Manufacturers of these life-saving devices will need to send in pre-market approval (PMA) applications if the proposed order is...

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