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Regulatory Operation & Submission
We ensure accurate, timely, and efficient regulatory preparation and submission
Navigate the intricate regulatory landscapes, achieve faster approvals, and maintain compliance across all markets.
SOLUTIONS
Clinical Trial Submissions
Marketing Authorizations
Vigilances
Lifecycle Management
Publishing
- Author, prepare, and submit appropriate clinical trial applications (CTAs, INDs)
- Write and review of responses to information requests from authorities
- Write and review Drug Master Files (DMFs)
- Lifecycle management
- Marketing application submission and management towards approval
- Support to comparability in case of production transfer
- Strategic planning for post-approval activities
- Case management and Adverse Event Reporting (AER)
- Periodic and aggregate safety reporting
- Risk management and labeling updates
- Pharmacovigilance system oversight
- Regulatory inspections and compliance
- Post-approval change management protocol (PACMP) and comparability protocol authoring & review at time of MAA/NDA/BLA dossier submission
- Define CMC regulatory strategy for post approval variation/supplement submission
- Author and review of post-approval supplement/variations
- Submission capabilities via the FDA Electronic Submissions Gateway (ESG), EMA Gateway, PSUR Repository, CESP
- Full e-publishing submission management (internal or external environments)
Global reach, local expertise
Capability to manage global or regional submissions in multiple markets, with experience in navigating the regulatory landscapes of major regions.
Efficient process & transparent communication
Established workflows and best practices that ensure timely and efficient regulatory preparation, review, and submission.
Clear and consistent communication with clients, keeping them informed and involved throughout the entire submission process.
Multidisciplinary team
A team of experts with diverse backgrounds in regulatory science, CMC, nonclinical, clinical research, scientific & medical writing, and data management, providing comprehensive support throughout the regulatory dossiers authoring and the submission process.
FAQs
Can you assist with interactions with regulatory agencies?
Yes, we facilitate interactions with regulatory agencies, including meeting requests, submission responses, and ongoing communication to support the approval process.
What types of submissions do you handle?
We handle various types of regulatory submissions, including:
1. INDs (Investigational New Drug applications): For initiating clinical trials.
2. NDAs (New Drug Applications): For obtaining marketing approval of new drugs.
3. BLAs (Biologics License Applications): For marketing approval of biologic products.
4. MAAs (Marketing Authorization Applications): For marketing approval in the EU.
5. CTAs (Clinical Trial Applications): For approval to start clinical trials in various regions.
6. ANDA (Abbreviated New Drug Application): For approval of generic drugs.
7. Post-approval submissions: Including supplements, amendments, and renewals.
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Related Glossary
Investigational New Drug (IND)
Clinical Trial Application (CTA)
Marketing Authorization Application (MAA)
New Drug Application (NDA)
Biologic License Application (BLA)
Questions? Get the answers by our expert team
No two product developments are the same, talk to our experts about your development challenges and we will provide your actional recommendations.