What we do
We help companies developing medical products define the regulatory pathway to market
Defining the Regulatory Pathway
We assess, define, plan, structure, analyze, and manage medical device, drug, and biologic development through the regulatory and clinical stages. We partner with our clients to create the most efficient pathway to success, sharing decades of experience that allows us to overcome barriers on the way to regulatory success.
Our Core Regulatory Services
Developing regulatory strategy
Facilitating discussions for due diligence and for strategic partnerships
Developing regulatory opinion memos including US FDA classification
Managing submission projects
Coordinating and preparing for FDA meetings
Preparing presubmission briefing documents
Developing clinical protocols
Performing data analysis and statistical planning for clinical reports
Preparing and submitting:
• Investigational Device Exemption and Investigational
New Drug applications
• 510(k) pre-market notifications
• De novo petitions
• Pre-market Approvals and New Drug Applications
• Humanitarian Use Device and Humanitarian Device
Exemption submissions
• Investigational Device Exemption and Investigational
New Drug applications
• 510(k) pre-market notifications
• De novo petitions
• Pre-market Approvals and New Drug Applications
• Humanitarian Use Device and Humanitarian Device
Exemption submissions
Preparing for Advisory Committee review
Developing strategy and submissions for EU Medical Devices and other international registrations
Our Specialized Services
Preparing clinical reports and Clinical Evaluation Reports (CER)
Securing labeling approval and maintaining compliance
Writing peer review publications
Preparing for FDA bioresearch monitoring inspections
Preparing literature reviews
Creating Quality Assurance systems and conducting testing including sterilization, biocompatibility, toxicity, and chemical toxicological risk assessments
Performing R&D Engineering including creating manufacturing instructions and device traceability records
Assessing and reporting adverse events
Conducting formative and summative usability evaluations for medical devices as part of the usability file and human factors report for FDA review
Assessing electrical safety, electromagnetic compatibility
Conducting software verification and validation testing
Evaluating device software to ensure it meets cybersecurity requirements, including performing threat assessment, modeling, and testing
Regulatory Compliance and Post-Market Support Services
Implementing complaint systems
Drafting and reviewing of promotional materials
Managing field corrections
Managing FDA Quality System Requirements and international inspections
Managing warning letters
Managing FDA Medical Device Reporting and vigilance for global adverse events reporting
Conducting Quality Systems and Supplier Quality Audits
Managing recalls
Our client companies represent all major medical specialties
- Cardiovascular
- Dermatology
- Drug Delivery
- ENT
- Gastroenterology
- General Surgery
- Gynecology
- Neurointerventional Radiology
- Neurology
- Ophthalmology
- Plastic Surgery
- Urology
GLOBAL REGULATORY SERVICES
United States
- Regulatory Strategy for devices, pharmaceuticals, and biologics
- FDA approvals
- Clinical trial applications
- Quality Systems certification
- Post-market
Europe
- Regulatory Strategy for devices, pharmaceuticals, biologics
- CE Marking
- ISO 13485 certification
- Literature Reviews and Clinical Evaluation Reports (CERs)
- Post-Market Vigilance
Canada
- Regulatory Strategy for devices, pharmaceuticals, and biologics
- Health Canada approvals
- Clinical trial applications
- MDSAP
- Post-Market
Latin America
- Regulatory Strategy and registrations for devices, pharmaceuticals, and biologics
- Clinical trial applications
Asia
- Regulatory Strategy and registrations for devices, pharmaceuticals, and biologics
United Kingdom
- Regulatory Strategy for devices, pharmaceuticals, and biologics
- UKCA Marking
- Post-Market Vigilance
Australia/New Zealand
- Regulatory Strategy for devices, pharmaceuticals, biologics
- Therapeutic Goods Administration approvals
- MDSAP
