Services

    Regulatory

    • Submissions (510k - IDE - PMA)

    • FDA US Agent Representation

    • FDA Liaison

    • 483 Responses

    • GMP/ISO Compliance Audits

    • QSR/ISO Audits

    • Consent Decree Resolution

    • Due Diligence Audits

    • QSR and cGMP Training Programs

    • Expert Witness Testimony

    Quality Assurance

    • Systems Development for FDA QSR and ISO Requirements

    • Supplier Audits for Quality Capabilities and QSR/cGMP/ISO Compliance

    • Software and Process Validation

    • Design History File Auditing

    • Design Control

    • Risk Analysis 

    Scientific

    • Clinical Trial Monitoring

    • Sterilization Validation and Sterilizer Selection/Qualification

    • Technical Writing

    • Aseptic Process Problem Resolution

    Other

    • Organizational Planning for Quality and Compliance

    • Personnel Recruitment and Selection

    • GAP Analysis for ISO and FDA Compliance

    • Research and Development Project Management

    • Packaging Design 

    • Packaging Equipment Selection and Validation

    • Packaging Suitability and Adequacy of Validation