Med Indite communications offers an extensive list of services to accommodate your research needs. The medical writing services offered by us encompass all medical communication requirements, across document types such as manuscripts (including original article, review article, case report and case series), abstracts, posters and slide decks etc for scientific journals and conferences. Regulatory and pharmacovigilance services include generation of ICH-GCP compliant protocol, CSRs, PSURs, safety summaries, PV plans, PSURs and CTD documents.
We also help in overall end-to-end clinical development of NCE/NBE molecules spanning from designing of clinical trial documents; conceptualize clinical study design, explore innovative approaches/models for proof of concept studies and most importantly development of clinical development plan and target product profile.
Our team comprises of clinical pharmacologist, medical writers and biostatistician. The capabilities and expertise of our team match the highest research standards; and are backed by outstanding academic credentials. In last 2-3 years, we have successfully executed several medical writing and statistical analysis projects on time.
Regulatory & Pharmacovigilance
Patient Safety summaries/Narratives
Safety Update Reports (PSUR)
Risk Management Plan (RMP)
Product Summary File (PSF)
Clinical/Non-Clinical Sections of the Common Technical Document (CTD) including Summaries and Overviews