Successfully secured venture funding and NIH grant funding for biotech and medical software innovative firms.
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.
SPECIALTY AREAS:
Strategic and Development Solutions:
Venture fundraising and grant proposal development for innovative firms
Scientific review and validation services for early stage firms
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 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)
