REGULATORY WRITING
Regulatory Writing Services
Expert regulatory documentation for FDA, EMA, and global submissions. ICH-compliant documents that meet agency expectations and accelerate approval timelines.
Regulatory Writing Services
Comprehensive regulatory documentation support
IND/CTA Submissions
Investigational New Drug and Clinical Trial Applications for regulatory authorities.
- Pre-IND meeting packages
- IND/CTA modules
- Annual reports
- Protocol amendments
NDA/BLA/MAA Submissions
Marketing authorization applications for drug and biologic approvals.
- CTD Module 2 summaries
- Module 3-5 documents
- eCTD publishing support
- Labeling documents
Briefing Documents
Strategic documents for regulatory agency meetings and consultations.
- Pre-submission meeting packages
- Type A/B/C meeting requests
- Scientific advice requests
- Orphan drug applications
Agency Responses
Timely, comprehensive responses to regulatory agency queries and deficiencies.
- Complete response letters
- Information requests
- Deficiency responses
- Day 120/180 responses
Safety Documents
Periodic safety reports and risk management documentation.
- PSURs/PBRERs
- DSURs
- Risk Management Plans
- REMS documents
Global Submissions
Regulatory documentation for multi-regional submissions worldwide.
- Country-specific dossiers
- Variation applications
- Renewal applications
- Post-approval commitments
Global Agency Expertise
Experience with major regulatory authorities worldwide
FDA
US Food and Drug Administration
EMA
European Medicines Agency
PMDA
Japan Pharmaceuticals Agency
Health Canada
Canadian Regulatory Authority
Need Regulatory Writing Support?
Contact us for a consultation and customized quote.