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Medical Writing
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MakroCare provides a wide range of high quality writing services for biotech, pharmaceutical and medical devices companies. Our team of qualified and experienced medical writers helps you bring out a wide range of regulatory, clinical, scientific and marketing communication documents allowing you to focus on your core competency areas.
MakroCare has comprehensive understanding of various regulatory guidelines such as
ICH-GCP, FDA, EMEA guidelines. With qualifications (MBBS, MD, PhD and Masters) in medical, pharmaceutical and other life science subjects, and expertise across therapeutic areas, MakroCare medical writers can help you prepare clear, concise, and high quality reports and documents for regulatory submissions, publications in peer-reviewed medical journals besides effective marketing communications. Our writers undergo continuous training with professional organizations like the EMWA, AMWA, RAPS and DIA.
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For more details on our outsourcing delivery model, please write to MakroCare with your requirements. Our Account Management and Client Acquisition Executive will respond to your queries within 24 hours.
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With years of hands-on experience behind them, our medical writers have the expertise to understand and analyze complex medical information and data, and thence 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 the Editing and Language Support team. Our medical writing team in US reviews documents intended for US submissions.
All documents are managed - created, accessed, shared, modified and stored in a validated web-based document management system.
MakroCare also provides medical writing services in Japanese, French and German languages.
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MakroCare Medical Writing Services Regulatory and Clinical MakroCare has experience in compiling and organizing regulatory submissions such as Investigational New Drug (IND) Applications, New Drug Applications (NDA), the Investigational Medicinal Product Dossiers (IMPD), and the CTD format
- Clinical Study Reports
- Clinical Trial Protocols
- Investigator Brochures
- Case Report Forms
- Informed Consent Forms
- Adverse Event Narratives (Subject Narratives/Safety Narratives)
- INDs, NDAs, ANDAs, BLAs,IMPDs, SmPCs
- Annual/Periodic Safety Reports - INDARs, PADERs, CTSURs, PSURs
- Statistical Analysis Reports
Publications MakroCare has an excellent team of qualified medical writers with a combined experience in having published several articles across different therapeutic areas in reputed international and national journals. MakroCare's medical writing team prepares all kinds of journal writings - article manuscripts, review articles, abstracts, and excerpts.
- Publications
- Journal Articles
- Manuscripts
- Abstracts
- Synopses
- Literature Reviews
- Conference/CME Documents
- Benefit/Risk Assessment Reports
Our writers are familiar with the guidelines of major medical journals including CONSORT, ICMJE guidelines.
Medical/Marketing Communications MakroCare has experience in producing high quality medical and marketing communications
- Manuscripts
- Abstracts
- Meta Analysis Reports
- Posters
- Slide Presentations
- Newsletters
- Content for Medical Websites