Medical Writing Services
Supporting partners across the full clinical development journey, from early-stage protocols to regulatory submissions and publications
Our Medical Writing Expertise
Comprehensive writing services for every stage of your clinical development
Clinical Writing
- Study protocols
- Clinical study reports (CSRs)
- Investigator brochures
- Regulatory submission dossiers (IND/NDA/MAA/CTA)
- Briefing packages
- Pediatric and orphan drug applications
- Real-world evidence reports
Safety Writing
- Development Safety Update Reports (DSURs)
- Periodic Safety Reports (PSURs, PBRERs, PADERs)
- Benefit–risk assessments
- Risk management plans
- Patient narratives
- Product labelling (CCDS, SmPC, USPI)
Diagnostics & Devices
- Clinical validation/performance reports
- Intended use statements
- State-of-the-art and scientific validity reports
- Clinical evaluation plans (CEPs) and reports (CERs)
- IDE submissions
Publications
- Manuscripts
- Abstracts
- Posters
- Speaker decks
- Literature reviews
- Oral presentations
Other Documents
- Informed consent forms (ICFs)
- Plain language summaries
- Regulatory white papers
- CMC writing
- Consumer health documents
- Training and educational materials
Why Work With Us?
Excellence in medical writing backed by expertise and compliance
Customer-First Mindset
Guided by transparent and ethical leadership
Regulatory Confidence
All documents comply with international standards
Quick Turnaround
Fast delivery without compromising quality
Experienced Team
Scientists and writers with cross-functional expertise
Global Perspective
Processes aligned with ICH, USFDA, EMA, CDSCO
Quality Assurance Services
Beyond writing, we ensure that your projects remain audit-ready and fully compliant at all times
Compliance Audits
GCP, GLP, and bioanalytical facilities audits
TMF Reviews
Trial Master File and documentation reviews
Vendor Qualification
Vendor and laboratory qualification
Protocol Verification
Verification of protocols, SOPs, CRFs, and eCRFs
Source Data Verification
SDV and data integrity checks
CAPA Planning
Process validation and corrective actions
Regulatory Inspection Readiness
Regulatory inspection readiness support
Training Programs
Tailored training programs on QA, GCP, and compliance
Audit Expertise You Can Rely On
Every audit is conducted by qualified professionals with years of hands-on experience
System Audits
Facilities, processes, SOPs
Study-Specific Audits
Protocols, investigator sites, data systems
Mock Inspections
Preparing teams for DCGI, USFDA, EMA, and other authority visits
Regulatory Alignment You Can Trust
Our services strictly follow international guidelines and standards
ICH-GCP, GLP, WHO-GCLP
21 CFR Part 11 (Electronic Records & E-signatures)
CDSCO and International Authority Requirements