ACCOMPLISHMENTS

  • Developed international regulatory strategies for device and biologic product submission, registration and launch in Latin America, Asia, EU and Canada.
  • Developed project management, GLP systems and document controls for  Malaria Vaccine development for NIH
  • Upgraded on-line graduate level course in international medical device development and commercialization for Regulatory Affairs Professionals Society (RAPS).
  • Upgraded and developed compliance training courseware in quality assurance and regulatory affairs for biologic, device and drug firms.
  • Reduced product development and launch time by 50% for drug and combination product facilities by applying integrated project management principles.

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