Medical & Scientific Writing
Medical & Scientific Writing
Our Medical & Scientific Writing (MSW) team brings to you a wide array of medical and scientific writing services catering to business needs across the entire healthcare spectrum. Be it the pharmaceutical, biotechnology, or medical device industries, our writers’ 3C formula helps craft success stories for our clients’ cross-functional collaboration in compliance with different geographies. Our agile, customizable workflows with robust processes offer an opportunity to accomplish targets in record timelines with the utmost quality no matter what the region or therapeutic focus is about. Seamless integration of writing operations with other essential functions like biostatistics and programming backed by innovative AI-ML based tools has made Genpro a strategic partner in the medical writing and digital automation space. We help our partners identify productivity bottlenecks and use automation technologies in medical writing and other processes at various stages of the product life cycle to enhance speed, quality, and cost savings.
Genpro’s Medical & Scientific Writing (MSW) team offers a wide array of medical and scientific writing services, from preparing clinical documents for industry conferences to meeting all needs for regulatory agency meetings.
We help our partners identify productivity bottlenecks and use automation technologies in medical writing and other processes at various stages of the product life cycle to enhance speed, quality, and cost savings.
Compelling Content, Scientific Solutions
- A perfect blend of experts from pharmaceutical, biotech, and medical industry
- Powerful network of global SMEs with a vast medical and scientific expertise
- Cross-functional work capabilities
- Conversant with different geographies
- Compliance-assured, timely delivery
- AI augmented agile workflows
Regulatory Medical Writing
Our experienced regulatory writers spread across the globe serve as an effective link between sponsors and their regulatory affairs consultants. Our research-backed regulatory submission services ensure a smooth regulatory approval process for our clients’ investigational medicinal products. With our vast experience in global post-marketing activities, we can help ensure safe and effective access to novel products for patients across the globe.
Our Regulatory Writing Services Include:
- Clinical Trial Protocol
- Clinical Study Report
- Common Technical Document
- Briefing Books/Manuscripts
- Plain Language Summaries
- Investigators’ Brochure
- Clinical Trial Disclosure
- Clinical Evaluation Report
- Country-specific labelling
- Informed Consent/Informed Assent
Safety Medical Writing
Our medical writers’ vigilant approach assists our clients in keeping track of minute safety alarms associated with their new drugs or devices. Our medical writers are trusted resources for various types of pharmaceutical risk management plans and other pharmacovigilance safety deliverables due to their in-depth understanding of the nitty-gritty risk management process and global team experience.
Our Key Safety Medical Writing Support Covers:
- Pharmacovigilance
- Aggregated Safety Reports
- Risk Management Plans
- Global RMP
- Medical Literature Monitoring
- Individual Case Safety Reports
- EU RMP
- Integrated Services with Epidemiology, Biostatistical Programming, & Medical Review
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Medical & Scientific Communications
Regardless of how clinically sound the data is, it is the art of storytelling that adds value to the product’s scientific significance. Our qualified team of publication support specialists and evidence analysts showcases unrivalled expertise in the development and dissemination of new scientific knowledge.
Our MedComm Services :
- Manuscripts, Conference Abstracts, and Scientific Posters
- Manuscript Revision
- Manuscript Peer Review
- Copyediting and Proofreading
- CME and Patient education Materials
- Author response to review feedback
- Expert group discussions, Panel Discussions, Peer-Review meetings
Our value-added services for medical affairs & medico-marketing professionals cover:
- Product leaflet (LBL)
- Reference tagging
- Reference pack development
- Clinical Content Validation (with or without VEEVA VAULT)
- Medical Information
- KOL/DOL Engagement
Serving satisfactorily global clients, Genpro regulatory writers is the one-stop solution for all your regulatory needs.
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