(289) 819-1339

                                            


The biologics and pharmaceutical industry is challenged by a regulatory environment that is increasingly demanding and stringently enforced.  As a result, companies are struggling to achieve and maintain an ongoing state of compliance and consequently, the ability to supply products to the market.

At Brevitas, we have a thorough understanding of compliance to Good Manufacturing Practices (GMP) and recognize the importance it plays in the ongoing success of our client’s businesses.

We support our clients through the entire drug regulatory lifecycle; from obtaining market approvals to help achieve the optimal time-to-market and to maintain ongoing compliance within all production operations.  We provide a full range of expertise in regulatory affairs, quality assurance, quality system management, regulatory compliance, technical services, and industrial operations.  During the course of our engagement, we continually educate your team to facilitate knowledge transfer and ensure long-term sustainability of quality enhancements.

  • New License Application
  • Post-Market Submissions, Amendments, & Variations Development
  • Post-Market Change Management
  • License Conformance Retrospective Gap Analysis
  • Non-Reported Changes Gap Assessment
  • Common Technical Document (CTD and e-CTD) Preparations & Amendments Development
  • Document Management
  • Deviation Management
  • Quality Risk Assessment
  • Change Control Management
  • Annual Product Quality Review
  • CAPA Plans/Effectiveness Development
  • QC GMP Laboratory Practices
  • Lot Release per Market Authorization
  • Stability Program Review
  • Sterility Assurance Review
  • Complaint Management
  • Regulatory Inspection Readiness
  • Regulatory Compliance Intelligence Development
  • Self-Inspection,Pre-Inspection Training & Mock Audits
  • Post-Inspection Remediation/Regulatory Inspection Response & Closure
  • Reporting to Agencies and Communication Management
  • Pharmacovigilance System Compliance Assessment