Quality Assurance & Regulatory Affairs

Excelya>Capabilities>Quality Assurance & Regulatory Affairs

Our Quality Assurance and Regulatory Affairs department provides a clear path to regulatory approval by ensuring data integrity and conformance. Our QARA Excelyates has years of experience on GxP regulated activities. We provide QA services to local and multinational pharmaceutical companies, medical devices companies, global CROs and medical associations.

Flexibility, experience in multidisciplinary projects and deep knowledge of applicable legislation ensure that your submission is ready for review by regulatory authorities.

Excelya's scope of action

What we deliver

Our services include:

Quality Assurance:

  • Writing, review and update of SOPs on GxP regulated activities
  • Gap analysis on SOPs and QA system
  • Risk assessment and risk management
  • Assistance for ISO 9001:2015 certification
  • Assistance for GDP certification for medical devices
  • Training personnel on GxP
  • Conducting internal and vendor audits
  • Evaluating external vendors
  • CAPA consultation and follow-up
  • Monitoring Local and EU legislation and updating guidelines’ to implement GxP requirements

For MAH:

  • Acting as local QA/QP for pharmaceutical products
  • Local adaptation of global SOPs and policies
  • Assessment and evaluation of subcontractors/ service providers
  • Audits and assessment of distribution centers
  • Management of product quality complaints (PQCs)
  • Assistance in case of recalls
  • Management of deviations/non-compliances
  • Root cause analysis and CAPA plan
  • Assistance in case of recalls
  • Conduct of self-inspections
  • Training of staff on applicable GxP guidelines and legislation

For clinical trials:

  • Training of Investigators and site staff on GCP (mutually recognized by TransCelerate Biopharma Inc.)
  • Training of site Coordinators
  • Conduct of clinical site audits and pre-inspections
  • Conduct and evaluation of central and/or local laboratories
  • Set-up of units for Phase I, BE/BA studies