Quality Management & Auditing

Quality is at the heart of our operations. We have a dedicated Quality Manager, and deploy a range of techniques to ensure that every facet of work done for clients is delivered faultlessly.

  • Use of Panacea’s complete set of SOPs
  • SOP review and writing – company specific
  • Training
  • Audit of a client’s pharmacovigilance systems
  • Local Authority inspection preparation and assistance

Systems Compliance

We have extensive experience of ensuring systems compliance.

  • Infrastructure and validated Database
  • Setting up and maintenance of EudraVigilance accounts

Communication and Management

We are responsive both in day-to-day communications, and act swiftly when alerting clients to key issues, or in crisis situations.

  • Responding to enquiries from Authorities
  • Identifying and communicating changes to Benefit / Risk
  • Crisis Management

Compliance Services

Our experienced team provides auditing services which can be invaluable for clients preparing for an Authority Inspection. We offer our own rigorous pre- inspection programme to make sure that all relevant procedures are in place, and in compliance with current legislation. Clients value Panacea’s thorough approach which ensures that any issues are addressed prior to the Authority Inspection. Panacea can also conduct routine audits as part of your external audit schedule.

  • Auditing
  • Quality Systems Reviews

Training

We have a wealth of experience in creating and delivering cost-effective training courses which are specifically tailored to suit our clients’ needs. These range from introductory to advanced level courses on a range of subjects, including:

  • Pharmacovigilance
  • Device Vigilance
  • Regulatory Affairs