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

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

CSR Authoring for a New Indication

Ophthalmology indication (Relatively new for the writer) Phase read more

Case Study for Clinical and Nonclinical Overviews

Client: Global Pharma Company read more

Case Study for 505B2 Application

Client: Global Pharma Company read more