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
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.