Our Services

Quality Assurance

OWLPHARMA features a comprehensive set of quality assurance services, effectively oriented for MAH, manufacturers and wholesale distributors.

Our professionals have the required experience and qualification to support you in the daily tasks of your company’s QMS, or to provide you an independent assessment of your company’s current processes (in-house or contracted processes).

Our Services include:
  • Audits (GMP; GDP; ISO 9001)
  • Quality management system implementation and review
  • Calculation of  Permitted Daily Exposure (PDE)
  • SOP preparation and review
  • Product quality review (PQR)
  • Risk assessment plans (e.g. GMP on excipients)
  • Training
  • Support on licensing/certification with competent authorities
  • Risk Assessment on Elemental Impurities