Medical Scientific Writing
MakroCare provides a wide range of high quality writing for biotech, pharmaceutical and medical devices companies. Our team of qualified and experienced medical writers helps you bring out a wide range scientific and marketing communication documents allowing you to focus on your core competency areas. With years of hands-on experience, our medical writers have the expertise to understand and analyze complex medical information and data, and hence prepare and produce complex documents and publications in accordance with relevant guidelines. Seamlessly supporting this process are qualified Subject Matter Experts (SMEs), Biostatisticians, Data Analysts, Quality Analysts, and Editing and Language Support team.Medical Writing Center of Excellence
MakroCare established a Medical Writing Center of Excellence (MWCoE) in 2005 that has nurtured Scientific Writing at MakroCare. MakroCare’s pool of Medical Writers is currently serving clients in different geographies – USA, Europe, Asia, RoW. With Clinical Writing, Regulatory Writing, Scientific Writing, and Writing on Medical Affairs and Marketing being the focus areas, MWCoE has been supporting clients in various delivery models – FSP, FTE, In sourcing and Fixed Budget model. Ably supported by Subject Matter Experts (Medical, Biometrics), MakroCare writers have experience working with international teams on a variety of documents such as Protocols, ICFs, IBs, SAPs, CSRs, Narratives, safety/periodic reports (PSURs, QSURs, INDARs), Clinical Overviews, Clinical Summaries, PIPs, RMPs.
- Experienced Writers
- Highly Qualified team - Doctors, PharmD/PhD, Masters in Pharmacy/Pharmacology, health related/clinical fields, and in life sciences.
- Hands-on experience in writing of Scientific Articles and Technical Reports as per regulatory guidelines in compliance with ICH-GCP standards.
- Full-fledged Subject Matter Experts – Regulatory, Medical, Biostatistics, Clinical, GxP and Quality Assurance
- Stringent QC
- Optimal Business models
- Flexible scale-up/scale down options
- Efficient Global Project Management