- Obtained early CE Mark certification for medical device firms by upgrading quality systems and technical files.
- Reversed FDA 483 citations and improved quality rating by clarifying issues with the FDA and pointing out FDA errors.
- Reduced development time by 2 years and saved $2 million in production costs as project manager in charge of production for drug-device combination product.
- Obtained clearances from FDA and notified bodies on complex IVD products in infectious disease, oncology and cardiac health by upgrading technical files and writing 510(k).
- Upgraded technical documentation and streamlined production, for blood and tissue products. Improved relations with FDA due to Warning Letter and Consent decree status.
- Developed Vaccine and Therapeutic regulatory strategy and documentation to for IND and BLA submissions.
- Developed global regulatory plans for device and biologic firms and while obtaining regulatory approvals.
- Obtained approvals of IND submissions for drug and biologic projects in infectious disease, metabolic health, reproductive health and cardiology.
- Developed and upgraded clinical adverse reporting system and improving reporting systems for adverse events, MDRs and unanticipated events.
- Developed malaria vaccine at NIH by using an integrated project management system to accelerate approval process.
- Translated foreign regulatory requirements and FDA standards into plans that were easy to implement.
- Served as regulatory and FDA liaison on design control teams and had an excellent record of success with FDA and Notified Bodies.
- Streamlined validation and regulatory plans to obtain product approval in Latin America, Japan, EU, Canada and U.S.
Strategic and Development Solutions:
- Global Regulatory Strategy
- Product Development and Scale-Up Programs
- GAP Analysis and Compliance services
- US Agent Representation – for foreign clients
- Staff Augmentation
- Strategic sourcing and supply chain
- Project Management
- Validation and process engineering services
- Regulatory Submissions and documentation (IND, NDA,BLA, eCTD, 510(k),IDE, PMA)
- CE Mark and International registrations
- Design Control and Development
- Product registration – Domestic and International
- Risk Management and evaluation
- FDA and Notified Body Liaison
- Usability and Human Factors
Quality System and Compliance Solutions:
- Quality Suite Development (GMP, QSR, ISO 13485, ICH)
- Quality Systems implementation
- Quality systems documentation
- Internal and Supplier audits
- Supply Chain Management
- CAPA Management and Compliance
- Equipment Validation and Qualification