Medical Writing Service

PharmXL provide full range of Medical writing services. Our experts have well experienced in Clinical, Regulatory and Drug Safety Reports writing. Our team undergo regular training to ensure the adherence of regulatory standards and have consistency across writing processes as per our client needs. We committed for excellent quality services delivery within time to our clients at highly competitive prices. We provide medical writing services entails the generation of well‐structured individual reports supporting Extensive medical writing programs, including.


Clinical Writing

  • Investigator Brochures
  • Clinical Sudy Protocols
  • Informed Consent Dcuments
  • Patient Diary Cards
  • Case Report Forms
  • Clinical Study Reports
  • SAE Narratives for Clinical Study Reports
  • Patient Safety Narratives
  • Clinical Summaries/Product Feasibility Reports for Medical Devices
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Regulatory Writing

  • Common Technical Documents
  • Clinical and non-clinical overviews
  • Summary of product characteristics
  • Pack Insert and Labels
  • Clinical expert statements
  • Briefing documents
  • NDAs/ANDA/IND
  • Company Core Safety Information (CCSI), Company Core Data Sheet (CCDS)
  • Summary of Product Characteristics (SmPC)
  • Literature and Brochure for medical devices

 

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Drug Safety Reports

  • Annual updates/ Annual safety report
  • Aggregate reports
  • (PSURs/PBRERs/PADERs etc.)
  • Risk management plans
  • REMS
  • Safety update reports (DSURs)
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Scientific Writing

  • Manuscripts
  •  Abstracts
  • Conference slide kits
  • Posters
  • Review articles
  • Drug monographs
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Other Strategic Writing

  • Marketing support and training materials
  • Marketing meeting reports
  • Promotional and educational material
  • Newsletters
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