Richard C. Tharin, MS, RAC, Global Regulatory Affairs Director, Founding Partner

 

ACCOMPLISHMENTS

  • 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:

 

  • 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)
  • Quality Systems implementation
  • Quality systems documentation
  • Internal and Supplier audits
  • Supply Chain Management
    • CAPA Management and Compliance
    • Equipment Validation and Qualification

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