Our Services

What We Offer

We provide medical writing services across all phases of drug development and offer expert guidance and support for the preparation of the following documents:

Clinical and Regulatory Documents

Clinical Study Protocols

Informed Consent Forms

Clinical Study Reports for Phase I to IV trials per ICH guidelines

Pharmacovigilance Documents

PBRERs

DSURs/IND Annual Reports

Risk Management Plans

120-day Safety Update Reports

Quality Control Documentation

100% QC of all documents against source documentation and style guides

QC to verify consistency within a document or between documents in a filing application

Testimonials

What Our Clients Say

“Thank you very much for making this report possible! I appreciate your thorough work and critical review.”

Director, Safety Physician

Multinational Pharmaceutical Company

“Thanks for all your work, flexibility, and diligence on this protocol amendment. You did a great job!”

Medical Writing Manager

Multinational Pharmaceutical Company

“Well done! And thanks again for your superhuman efforts in getting this CSP over the line – it’s certainly been a challenge.”

Director, Global Submissions

Top CRO