Medical Writing services

MakroCare provides a wide range of high quality writing services for the biotech, pharmaceutical and medical devices companies across the globe. Our team of qualified and experienced medical writers is well equipped to write a wide range of regulatory, clinical, scientific and marketing communication documents.

MakroCare has comprehensive understanding of various regulatory guidelines such as ICH-GCP, FDA, EMA guidelines. Our team consisting of persons with qualifications in medical, pharmaceutical and other life science subjects (MBBS, MD, PhD and Masters) has expertise across therapeutic areas.

MakroCare medical writers can help you to prepare clear, concise, and high quality reports and documents for regulatory submissions, publications in peer-reviewed medical journals and effective marketing communications. Our writers undergo continuous training with professional organizations.

OUR MEDICAL WRITING FOCUS AREAS

Regulatory Writing (Clinical & Non-clinical) Scientific
  • Synopses, Protocols
    and protocol amendments
  • Investigators Brochure
  • Informed Consent Forms
  • Clinical Study Reports
  • Clinical Summaries and Overviews
  • Study Reference Manual
  • CTD modules
  • Annual/Periodic Safety Reports –
    PSURs/ PBRERs, PADERs, DSURs and RMP
  • Non-clinical Study Reports
  • Non-clinical Summaries and Overviews
  • Abstracts
  • Manuscripts
  • Write-ups
  • Slide deck
  • CME Documents
  • Poster Content Writing

With years of hands-on experience our medical writers have the expertise to understand and analyze complex medical information and data and prepare complex documents and publications in accordance with relevant guidelines. Helping them in 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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