Regulatory Affairs

Compliance to Good Manufacturing Practices (GMP)

team of consultants discussing regulatory affairs

The biologics and pharmaceutical industry is challenged by the regulatory affairs 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.

Full Range Expertise

Regulatory Affairs and compliance blocks

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 and regulatory compliance. During the course of our engagement, we continually educate your team to facilitate knowledge transfer and ensure long-term sustainability of regulatory requirements.

Regulatory Affairs Services

Regulatory Affairs

  • New License Application
  • Post-Market Submissions, Amendment, & 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

Regulatory Compliance

  • Regulatory Compliance Intelligence Development
  • Regulatory Inspection Readiness
  • Inspection Readiness
  • Self-Inspection, Pre-Inspection Training & Mock Audits
  • Post-Inspection Remediation/Regulatory Inspection Response & Closure
  • Reporting to Agencies and Communication Management
  • Pharmacovigilance System Compliance Assessment

Let's Get Started!

Our expert consultants will guide you step-by-step through the process of achieving tangible results and long-lasting improvements.