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

 

What Does The First Biosimilar Approval By The USFDA Mean For The Pharmaceutical Labeling Industry?


Bindu Narang

The advent of generic products made a significant contribution to patients worldwide by providing access to affordable medicine. Biosimilars will deliver a similar promise. However, the regulatory challenges in the approval of biosimilars are very different and more complex because unlike generics,...

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Dr. Suhasini Sharma

Pregnancy Exposure Registries & The New FDA Pregnancy & Lactation Labeling Rule (PLLR)


Dr. Suhasini Sharma

[This post discusses the importance/benefits of pregnancy registries; and the new labeling rule – PLLR – proposed by the FDA/EMA for pharmaceutical and biological products used by Pregnant and Lactating women.] Women of childbearing potential form a sizable proportion of the population...

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Dr. Chitra Lele, Chief Scientific Officer, Sciformix

Pharmacovigilance Outsourcing: The Need for Parity Between Local Presence and Offshore Capabilities in a Global Delivery Model


Dr. Chitra Lele Ph.D.

[This post analyzes considerations and requirements of a global delivery model for pharmacovigilance.] The drug safety landscape continues to evolve with the dynamic pharmaceutical marketplace. Increased regulatory requirements, importance of emerging markets, global partnerships across multiple stakeholders and shifting mix of small...

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