What we offer

Authoring, editing, and review services to produce comprehensive, high-quality, submission-ready documents for all stages (Phase I to IV) of clinical development, with a team of experienced writers from life sciences and medical backgrounds, trained under the ICH guidelines 

Who is it for

Clinical R&D, regulatory affairs, safety, pharmacovigilance, and medical writing teams

Why it's important

Document clinical development findings comprehensively

Reduce compliance risks with information accuracy and quality

Meet regulatory submission deadlines across markets

How we deliver

Process

Our team of experts offer regulatory authoring services both as part of extensive clinical trial programs and as stand-alone services, across all stages in product development.

The diverse range of regulatory documents we support include Clinical protocols, informed consent documents, case report forms, clinical evaluation reports (CERs), certificate of suitability (CEP), investigator’s brochures, quality documents, CMC documents, CTD documents, Integrated Summary of Safety (ISS) , Integrated Summary of Effectiveness (ISE), Interim data summaries, Clinical study reports (CSRs), Patient narratives, Investigational New Drug Applications (IND), New Drug Application (NDA), Annual reports, Safety data sheets (SDS), Patient information leaflet (PIL), label and carton content, pregnancy and lactation labeling rule (PLLR) updates, and Literature reviews.
 

What makes us different

Medical expertise blended with modern technology

First-time-right documentation

Interdisciplinary team of medical writers

20
Therapy areas
100
Regulatory compliance
2,000
Regulatory documents authored