Regulatory Affairs
Providing end-to-end support, ensuring compliance, minimizing delays, and securing timely approvals.
Navigating Global Regulations with Confidence
Globyz Clinical Solutions provides practical regulatory strategy and submission support aligned with the product, development stage, target jurisdiction, evidence package and agreed pathway. This service is provided in close collaboration and coordination with CEBIS USA LLC, its U.S. affiliate and clinical research arm. Clinical studies are conducted under the integrated affiliate framework of Globyz Clinical Solutions and its clinical research arm, CEBIS USA, through a coordinated delivery model.
Global Reach
FDA · EMA · PMDA · NMPA
End-to-End Support
Strategy to Approval
Regulatory Excellence
Compliance across 50+ global markets
Our Core Services
Delivering precision, strategy, and expertise at every phase of the regulatory process.
Regulatory Strategy & Planning
We help sponsors identify regulatory questions, information gaps, submission dependencies, and decision points before timelines and documents are finalized.
- Regulatory pathway and gap assessment
- Health Canada clinical trial application planning and support
- Regulatory input to protocols, development plans, and submission sequences
- Meeting preparation and support for health authority interactions
- Regulatory intelligence relevant to the agreed product and jurisdiction
Submission and Lifecycle Support
The exact dossier and operational scope is confirmed for each assignment.
- Clinical trial applications, amendments, notifications, and responses
- Regulatory document coordination and publishing support where agreed
- Deficiency or information request response planning
- Post approval and lifecycle maintenance support where applicable
- Regulatory correspondence tracking and decision documentation
Compliance & Regulatory Operations
- Deficiency & Query Responses – Expert handling of FDA 483s, EMA objections, and queries
- GMP, GCP & GLP Compliance – Support for manufacturing inspections, audits, and quality compliance
- Import/export permits, clinical trial licenses, and product registrations
Pharmaceutical Manufacturing Support
- Drug Master Files (DMF), Active Substance Master Files (ASMF), and CMC documentation
- Variations, renewals, and post-approval maintenance for marketed products
- Quality & compliance support for facility inspections (FDA, EMA, WHO GMP)
Documentation & Intelligence
- Professional dossier preparation (eCTD, CTD, NeeS) and submission tracking. Certified translations (regulator-compliant, including 21 CFR Part 11 where applicable)
- Real-time regulatory intelligence on evolving guidelines (ICH, GMP, GCP, local requirements)
What You Receive
Typical deliverables may include a regulatory plan, responsibility matrix, document list, submission schedule, review comments, meeting materials, authority correspondence support, and a decision log.
Regulatory Plan
Tailored roadmap aligned to your product, jurisdiction, and stage.
Responsibility Matrix
Clear ownership of tasks across sponsor and Globyz teams.
Document List
Full inventory of required regulatory documents for the assignment.
Submission Schedule
Milestone-based timeline for each submission activity.
Review Comments
Structured feedback on regulatory documents and dossier content.
Meeting Materials
Briefing packages and presentation support for HA meetings.
Correspondence Support
Authority correspondence drafting and coordination support.
Decision Log
Documented record of all key regulatory decisions made during the engagement.
Work With Our Regulatory Team
Tell us the product, development stage, jurisdiction, intended submission, current documentation, and target timeline. We will confirm the appropriate regulatory scope and responsible delivery team.