Regulatory
Medical Writing

Ensuring timely and successful delivery of submission documents, every time

5,000+
Documents Developed
7/ 10
Partnered with 7 of top 10 Industry Leaders
All
Therapeutic Areas Managed
7+
Years of Average Writing Experience Across the Team
150+
Indications Worked Upon

Documents Supported

Protocols &
Protocol Amendments
Informed
Consent Documents
Clinical
Study Report
Investigators'
Brochure
eCTD Modules
Labelling
Solutions

Protocols & Protocol Amendments

  • Conceptualization of protocol
  • Well versed with SPIRIT, TransCelerate, ICH M11 Guidelines
  • Experience in working on varied protocol templates across different clients
  • Experience across different phases and complex indications
  • In-house strong statistical support
  • Supported all types of studies including exploratory, therapeutic confirmatory, post-approval studies
  • Developed protocols for randomized, open-label, blinded, double-blinded, placebo controlled, active controlled, add-on, single-centered and multi-centered studies

Key Therapeutic Areas Experience

Submissions to Global Health Agencies

Publishing

Collation of Appendices and relevant documents

Formatting as per global submission requirements/ client specific templates and metadata checks

Submission ready checks including hyperlinking and formatting

eCTD compliant documents like CSRs, IBs, Protocols

Utilization of ISI Toolbox, TRS Toolbox, Acrobat ProDC, TRS Writer

Data consistency, integrity, accuracy checks and style guide compliance

Dedicated Quality Control Group

Dedicated and expert Quality Control group capable of quality check for any and all types of Regulatory Medical Writing Documents

Sole partner for Quality Control for TAs like Immunology, Oncology, and Neuroscience for a sponsor

Customized QC checklists for every type of document

Successfully undergone multiple audits by major clients, with no major or critical findings reported

CSR Automation

Functionalities of Our AI Driven Tool

Inbuilt CSR template (ICH E3 guidelines, TransCeralate)

Provision of automatically copying the relevant data from the protocol and other source data

End to end workflow (review, QC, editing and approval) designed in the tool

Interactive Dashboards

Audit Trail

21 CFR Part 11 Compliance

Case Studies
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