Our Medical Writing Services Include
Clinical Study Documents
Preparation of clinical study reports (CSRs), investigator brochures (IBs), clinical trial protocols, safety narrative and other essential regulatory documents in compliance with ICH and regional guidelines.
Aggregate Safety Reports
Development of pharmacovigilance documents such as Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADER), Annual Safety Reports (ASR) etc.
Medical and Scientific Publications
Authorship and editing of peer-reviewed journal articles, conference abstracts, posters, and presentations to communicate scientific findings effectively.
Health Communication Materials
Creation of patient information leaflets, educational materials, and healthcare training documents tailored for diverse audiences.
Regulatory Documents
Regulatory submission documents such as Common Technical Document (CTD) modules such as nonclinical and clinical overviews and summaries, expert reports, safety and efficacy summaries.
Reference Safety Information
Preparation and update of Company Core Data Sheet (CCDS), Package Inserts (Product Information) and Patient Information Leaflets; or any update of particular sections of RSI according to regulatory requirements.
Why Choose Pharmnova for Medical Writing?
Experienced Team
Expertise from medical professionals with extensive industry experience.
Quality and Compliance
Adherence to global regulatory standards, ensuring compliance and accuracy.
Customized Solution
Tailored solutions to meet client-specific needs and timelines.
Established Process
Commitment to clarity, quality, and impactful communication.
Transforming Data into Clear, Accurate, and Compliant Documents!
From regulatory submissions to scientific publications, our medical writing team ensures your data is presented in a concise, impactful, and compliant manner, helping you achieve your objectives with confidence.
Let Pharmnova turn your data into actionable insights and compelling communication.