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Appointment
  • I 202, silver harmony, Shakun Glory Road, Gota. Ahmedabad - 382481
  • Mon To Sat - 10:00 AM To 6:00 PM

Medical Writing

12+

Years of Experience

Medical Writing

Our dedicated team collaborates closely with biostatistical, pharmacovigilance, project management, and clinical data management teams to deliver accurate, timely, and compliant documents.


Medical & Scientific Writing Support for Diverse Document Types:

  • Regulatory Documents
    • • PIP part F and part A
    • • PIP Key Elements Form
    • • Nonclinical/CMC documents
    • • Orphan Drug Annual Report
    • • Actual Orphan Drug Application
    • • Original Pediatric Written Request (FDA)
    • • PIP Scientific Document (parts B-E, includes waiver)
    • • Orphan Drug supporting Briefing Books (BB) and updates
    • • Module 2.4, 2.5, 2.6 & 2.7 (Clinical & Non-clinical summaries)
    • • Proposed Pediatric Study Request/Pediatric Study Plan (PPSR/PSP) + modifications
    • • Correspondence with Health Authorities and Cover Letters including Meeting requests.
    • • Scientific Advice Document/Documents for EU Scientific Meetings and other ROW HA meetings
    • • Clinical Overview (CO) to support global submissions, (c)MAA, (s)BLA/(s)NDA, Type II variations, etc.
    • • PIP Update (request for PIP modification), including final consolidation of comments after HA approval

  • Clinical Study Protocol & Related Documents

    • • DSMB charter
    • • Statistical Analysis Plan
    • • Protocol Registration Forms
    • • Protocols for epidemiology studies
    • • Protocol Clarification Communication
    • • List of anticipated events in protocols
    • • Informed Consent Form (including Master ICF)
    • • Clinical Study Protocols for Phase 0, I to IV studies
    • • Amendments/Revisions for Clinical Study Protocols
    • • Protocol Synopsis / Protocol design / Protocol Outlin
    • • Responses to Ethics Committees and Regulatory Agencies

  • Clinical Study Report (CSR) & Related Documents

    • • PK Reports
    • • Modeling Reports
    • • CSR Appendices
    • • Clinical Subject Narratives
    • • DMC/DSMB Report Package
    • • CSRs for Epidemiology studies
    • • CSR Addendum/Erratum/Synopsis
    • • PRCI (Public Release of Clinical Information) Health Canada
    • • CSR body (full, abbreviated, synoptic) for Phase 0, I-IV studies

  • Investigator’s Brochure (IB) And Related Documents

    • • Writing of product information
    • • Writing of any PK data summary
    • • Writing of clinical data summary
    • • Writing of nonclinical sections of IB
    • • Writing of reference safety information (co-ordination only)
    • • IB + IB updates (clinical sections + other contributions: PK, safety, PV, CMC) + coordination of finalization

  • Drug Safety and Risk Management Document Types

    Our medical writing experts ensure that every document meets the highest standards, aligning with global regulatory requirements. By providing comprehensive support throughout the lifecycle of a clinical trial, from protocol development to final reporting, we help our clients expedite the submission process and move closer to achieving their clinical and commercial goals. With Lambda Therapeutic Research and Novum Pharmaceutical Research Services, you can be confident that your regulatory documents are not only meticulously crafted but also strategically aligned with your product’s development and market approval needs. Our team remains up-to-date with the latest regulatory guidelines, ensuring all submissions meet the evolving demands of regulatory agencies worldwide, ensuring smooth transitions from study initiation to final approval.