Regulatory Affairs & Compliance

Brevitas Consulting - Pharmaceutical, Biopharmaceutical, Chemical, Food and Beverage

Compliance to Good Manufacturing Practices (GMP)

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.

Compliance to Good Manufacturing Practices (GMP)

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.

Brevitas Consulting - Pharmaceutical, Biopharmaceutical, Chemical, Food and Beverage
Brevitas Consulting - Pharmaceutical

Full Range Expertise

We support our clients through the entire drug regulatory life-cycle, 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.

Brevitas Consulting - Pharmaceutical

Full Range Expertise

We support our clients through the entire drug regulatory life-cycle, 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.

Regulatory Affairs

  • 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

Quality Assurance & Management

  • 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 Compliance

  • 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

Case Studies

Brevitas Consulting - Pharmaceutical Case Studies

OSE Preparation

An international client required support to address recent findings from an FDA inspection and prepare for an On-Site Evaluation (OSE) by the Biologics & Genetic Therapies Directorate (BGTD). Brevitas provided GMP advice and coaching which facilitated the successful execution of the OSE, with no observations.

Quality Notification Management

In order to meet the constant demand for their products, our Global Pharmaceutical client retained the services of Brevitas consultants to provide compliance support and address open Quality Notifications by special investigation and effective root cause corrective actions.

SOP Consolidation

Brevitas consultants provided technical and compliance expertise to a leading Canadian pharmaceutical company for the revision and creation of global GMP, GLP and GCP Standard Operating Procedures (SOPs). Within 5 months, the number of global R&D SOPs was reduced from 100 to 50, to help achieve lean operations.

Criticality Assessment

Our client required an approach to categorize critical utility system components, to allow for the adjustment of maintenance frequencies and verify the accuracy of information within SAP. Brevitas developed a standardized assessment method and successfully applied it to 30 critical utility systems across the site.

Facility Renovation

Brevitas consultants managed and coordinated the design, construction, and commissioning of an engineering capital project for a global pharmaceutical company. Brevitas consultants successfully addressed compliance issues, remediate potential risks, and improve production capacity by applying their expertise in project management and technical assurance.

DMS

The Brevitas team supported the replacement of three legacy systems with a global document management system that significantly improved productivity and reduced operating costs of multiple systems and streamlined business practices.

Inspection Readiness

After a few years of compliance issues, our Global Pharmaceutical client retained the services of the Brevitas team to provide strong leadership and project management support in preparing their staff for a regulatory inspection.

Deviation Management

After dealing with ongoing compliance issues, our global pharmaceutical client retained the services of Brevitas to provide strong leadership and project management support in managing and improving their deviation management quality system.

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