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

 

Reporting of SUSARs Based on Aggregate Analysis – Statistical Considerations


Michael Zelasky

In December 2015, the FDA released the draft guidance Summary of Assessment for IND Safety Reporting1. The draft guidance includes recommendations on reporting of SUSARs (Serious and Unexpected Suspected Adverse Reactions) based on aggregate analysis. Aggregate analysis is stated in the Code...

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US FDA Updates Draft Guidance on Comparability Protocols for Human Drugs and Biologics (Chemistry, Manufacturing, and Controls Information)


Vivek Padalalu

The United States Food and Drug Administration (FDA) has released a draft Guidance on “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information”, Revision 1, dated 19 April 2016. This guidance provides human drugs and biologics application holders with...

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FDA issues New Draft Guidance on Data Integrity and Compliance with cGMP


Vivek Padalalu

The mission of all health authorities is to ensure the quality, safety and efficacy of drug products by carefully monitoring drug manufacturers’ compliance with their current Good Manufacturing Practice (cGMP) regulations. The cGMP regulations for drugs contain minimum requirements for the methods,...

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