Regulatory Strategy & Compliance
Navigate complex regulatory landscapes with our expert guidance and strategic approach
Comprehensive Service Offerings
We provide specialized solutions tailored to your specific needs and challenges
Expert preparation and management of FDA, EMA, and global regulatory submissions
Stay ahead with insights on evolving regulations and compliance requirements
Comprehensive assessment of regulatory gaps and strategic remediation planning
Development of compliant regulatory documentation and submission packages
Thorough audits to ensure adherence to regulatory standards and requirements
Expert assessment for mergers, acquisitions, and partnership opportunities
Regulatory Affairs Solutions
EU Market
- Development of Regulatory Strategy for CE mark Certification
- CE Technical Documentation Gap Analysis for EU MDR
- CE Technical Documentation Remediation/Preparation as per EU MDR or IVDR
- Preparation of Clinical Evaluation Plan, Execution of Literature Search & preparation of Clinical evaluation report in accordance with MDCG & EU MDR requirements
- Preparation of SSCP (Summary of Safety and Clinical Performance) as per MDCG Guidance and EU MDR Requirements
- Preparation of PMS Plan, PSUR, PMCF Plan, PMCF Report as per EU MDR
- Quality Management System Development as per ISO 13485 requirements
- Obtaining Free Sale Certificate
- Vigilance Reporting
- EU Representation
- UDI Entry into EUDAMED Database
Our Regulatory Strategy Process
Our systematic approach ensures regulatory success at every stage of your product lifecycle
Assessment
Comprehensive evaluation of your product, market, and regulatory requirements
Strategy Development
Creation of tailored regulatory roadmaps aligned with business objectives
Documentation
Preparation of compliant regulatory submissions and supporting documents
Submission & Liaison
Management of regulatory submissions and agency communications
Post-Approval Compliance
Ongoing support to maintain regulatory compliance throughout product lifecycle
What Our Clients Say
Burwood Biotech's regulatory expertise was instrumental in securing FDA approval for our novel therapeutic. Their strategic approach saved us months in the approval process.
Dr. Sarah Johnson
Chief Scientific Officer, NexGen Therapeutics
Ready to Navigate the Regulatory Landscape?
Contact our regulatory experts today to discuss your specific needs and challenges.
Ready to Get Started?
Our team of experts is ready to help you navigate the complex regulatory landscape.
- Expert consultation
- Tailored solutions
- Ongoing support