Regulatory Strategy & Submission Support
We help you navigate complex regulatory pathways with tailored strategies and hands-on submission support. From early planning to final approval, our goal is to ensure full compliance and accelerate your product’s path to market.
Unlock Your Path to Global Pharmaceutical Success
Partner with us to navigate the complexities of regulatory affairs and ensure your products meet all necessary compliance standards for successful market entry.
✓ Expert guidance tailored to your specific regulatory needs and market requirements.
✓ Streamlined processes that save you time and reduce the risk of submission delays.
Frequently Asked Questions
What services do you offer for regulatory compliance?
We provide a range of services including regulatory strategy planning, dossier preparation (CTD/eCTD), submission support, and post-approval maintenance to ensure compliance with global regulations.
How do you assist with dossier preparation?
Our team specializes in preparing comprehensive CTD/eCTD dossiers tailored to specific market requirements, ensuring all necessary documentation is accurate and complete for successful submissions.
What regions do you cover for submissions?
We cover various regions including the UK, EU, CIS countries, MENA, ROW markets, and Latin America for regulatory submissions.
Can you help with post-approval variations?
Yes, we assist with managing post-approval variations, ensuring that all changes comply with regulatory requirements and are submitted in a timely manner.
What is your approach to regulatory strategy?
Our approach involves a thorough analysis of market-specific regulations, risk assessment, and strategic planning to facilitate smooth product approvals and market entry, tailored to each client’s needs.
Document Review
Thorough review of regulatory documents to ensure accuracy, compliance, and submission readiness.
Dossier Preparation Services
End-to-end preparation of CTD/eCTD dossiers to meet global regulatory authority requirements.
Labeling and Documentation
Creation and review of compliant product labels and regulatory documents aligned with market-specific guidelines.
Managing Post-Approval variations
Support with planning, compiling, and submitting variations to maintain product compliance after approval.
In-Depth Regulatory Intelligence Services
Risk assessments and regulatory intelligence for informed decisions.
GAP Analysis
Identify regulatory gaps in your data and documentation to strengthen compliance and submission success.
Risk Assessments
Thorough review of regulatory documents to ensure accuracy, compliance, and submission readiness.
Clinical Module writing
End-to-end preparation of CTD/eCTD dossiers to meet global regulatory authority requirements.
Quality Assurance
Creation and review of compliant product labels and regulatory documents aligned with market-specific guidelines.