Comprehensive Regulatory Solutions
End-to-end expertise across the product lifecycle. We transform regulatory hurdles into strategic advantages.
Full-Service Drug Development
Comprehensive regulatory support from preclinical through approval. We become an extension of your team, providing end-to-end oversight across the entire drug development lifecycle.
Regulatory Strategy
Before the first document is written, the path must be clear. We provide high-level strategic oversight to align your scientific data with regulatory expectations.
- ●Target Product Profile (TPP) Development
- ●Regulatory Pathway Selection
- ●Pre-IND/CTA Meeting Preparation
- ●Orphan Drug Designations
CMC & Quality Compliance
Manufacturing is often the hurdle that stalls approval. We bridge the gap between technical operations and regulatory requirements.
- ●Module 3 authorship and review
- ●GMP Compliance Audits
- ●Stability data assessment
- ●21 CFR Part 11 Document Management
FDA Submissions
Flawless execution of major submissions. We handle the details so you can focus on the science.
- ●IND/NDA/BLA Authoring
- ●eCTD Publishing & Validation
- ●505(b)(2) Applications
- ●Fast Track & Breakthrough Requests
Global Submissions
Expanding beyond the US? We navigate international regulatory landscapes with ease.
- ●EMA MAA Preparation
- ●Health Canada Submissions
- ●PMDA Consultations
- ●Rest of World (ROW) Strategy
Lifecycle Management
Maintaining compliance post-approval is just as critical as getting approved.
- ●Post-Market Variations
- ●Annual Reports
- ●Labeling Updates
- ●Safety Reporting
Due Diligence
Assess risks and opportunities before making critical business decisions.
- ●Regulatory Gap Analysis
- ●M&A Support
- ●Portfolio Assessment
- ●Risk Mitigation Strategies
eCTD Publishing
Professional electronic submission publishing ensuring first-time acceptance by FDA and global regulators.
- ●eCTD v3.2.2 & v4.0 Compliant
- ●FDA Gateway Transmission
- ●Multi-Region Publishing
- ●Technical Validation & QC
US Agent Services
FDA-required US Agent representation for foreign establishments importing regulated products.
- ●FDA Liaison Services
- ●FURLS Registration Support
- ●Inspection Coordination
- ●US Business Hours Coverage
Ready to Accelerate Your Program?
Schedule a consultation to discuss your specific regulatory challenges and how we can help you navigate them.
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