Helping companies around the world navigate the regulatory maze

Quality Services

Our dedicated team of experienced consultants can help you with all your quality needs. Many of our consultants have over 20 years of experience in the pharmaceutical industry—and you can leverage this expertise to increase efficiency throughout the regulatory process. We work to help clients around the world develop customized solutions that meet their regulatory affairs needs, including specialized consulting in quality assurance activities for clinical trial material and commercial products.

Specialized Services

  • Provide Importer of Record Services
  • Assess, Develop & Implement GMP Quality Systems
  • Facilitate Agency Inspections
  • Clinical & Commercial Product Release
  • Preparation & Review of Quality Agreements
  • GMP & GCP Audits and Training
  • Stability Protocol Preparation
  • HPFBI / NHPD Site Licensing
  • Preparation & Review of Annual Reports in US / Canada
  • Audits of Trial Master Files, Clinical / Investigator Sites, CRO & Clinical Laboratories (vendors), Clinical / Safety database, as well as Clinical Study Reports (CSR)
  • Review of protocols, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Investigator’s Brochures (IBs), Clinical Study Reports (CSRs)
  • Monitoring of Clinical Study Sites
  • Submission of trial documents to ethics committees / institutional review boardsas well as regulatory / competent authorities
  • Assistance during inspections performed by regulatory authorities
  • Assistance / guidance for studies on clinical hold

Technical Services

  • Analytical Validation Review
  • Process Validation Protocol & Report Review
  • Packaging Qualification Protocol & Report Review
  • Supplier / Subcontractor Qualification
  • Preparation of Site Validation Master Plan
  • Assistance / guidance for studies on clinical hold
  • Site / Study Management

We provide our clients with specialized consulting in quality assurance activities for clinical trial material & commercial products

Request a consultation with an Strategic Regulatory Services expert