Regulatory Dossier Preparation & Submission
End-to-End Compliance. Global Acceptance.
Navigating regulatory submissions requires precision, expertise, and global alignment. At Regusol, we provide comprehensive support for dossier preparation, review, gap analysis, and submission—ensuring full compliance with both national and international regulatory frameworks.
Our Core Dossier Services
We handle complete lifecycle management of regulatory dossiers:
✔ CTD, eCTD, ACTD & country-specific formats
✔ New Drug Applications (NDA)
✔ Variations & Renewals
✔ Product Lifecycle Management
Domestic Regulatory Services
We bring deep expertise in handling domestic regulatory procedures via ONDLS, including:
- Manufacturing License (Application & Renewal)
- GMP / GLP / WHO-GMP Certifications
- COPP (Certificate of Pharmaceutical Product)
- FSC (Free Sale Certificate)
- Product Licensing
Scope of Services
📊 Regulatory Readiness
- Application filing
- Gap analysis
- Inspection readiness assessment
📄 Documentation Excellence
- Technical dossier development
- Regulatory documentation review
- SOP structuring & control
🔍 Inspection Readiness
- Pre-inspection preparation
- Mock audits & compliance checks
🔄 Post-Inspection Compliance
- CAPA (Corrective & Preventive Actions)
- Risk mitigation strategies
GMP Consulting Services
Ensuring Manufacturing Excellence
We help organizations align with global GMP standards through:
- GMP implementation & compliance assessment
- SOP development & documentation control
- Quality Management System (QMS) setup
- Deviation, CAPA & change management
- GMP training & awareness programs
GLP Consulting Services
Our GLP services ensure data reliability and regulatory acceptance:
- GLP system implementation & audits
- Laboratory SOPs & documentation
- Data integrity compliance (ALCOA+)
- Equipment qualification & validation
- Internal audits & inspection support
Additional Quality & Compliance Services
We extend our expertise across
Validation Services
- Process Validation
- Cleaning Validation
- Equipment Qualification
- Computer System Validation (CSV)
Regulatory Intelligence
- Market entry strategy
- Country-specific compliance insights
Supplier & Vendor Audits
- Risk-based vendor qualification
- Supply chain compliance
Training & Workshops
- Technical training programs
- Regulatory awareness workshops
Why Choose Regusol?
End-to-end regulatory support Deep global & domestic expertise Inspection-ready systems Future-ready compliance strategy
Final Impact
With Regusol, you achieve:
Faster approvals Strong regulatory positioning Seamless global expansion Audit-ready operations