Quality Assurance & Regulatory Affairs

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A strong formula for submission

Regulatory Affairs

Our Regulatory Affairs department provides a clear path to regulatory approval by ensuring confident, accurate and timely document submissions. Our regulatory team has up to 20 years of experience across all therapeutic area, phases and industries. We support marketing authorisation application across the product lifecycle, including market access and promotional material compliance.

We leverage flexibility, experience in multidisciplinary projects, excellent relationships with health authorities and deep knowledge of the regulatory environment to ensure that your submission is ready for review and timely conclusion.

Regulatory Affairs

What we deliver

Our clinical trial services take you from initiation to follow-up to completion. They include:

  • Development: Core documentation regulatory review & submission strategy
  • Submission/review: EU planning, EU CA/EC submission, answer to CA/EC questions
  • Activation: Public registry registration, FVLP
  • Conduct: Amendment follow-up, public registry update, completion

Our marketing authorisation and post-marketing authorisation services include:

  • Μarketing Authorisation Applications for medicinal products (DCP/MRP/National Procedures)
  • Local activities following Centralised Procedures
  • Maintenance of the Marketing Authorisations, Variations and Renewals
  • Transfers of Marketing Authorisations
  • High quality translations of the Summaries of Product Characteristics, Labeling and Patient Leaflet
  • Effective collaboration with the authorities and follow-up of submissions, to ensure timely conclusion of the procedures
  • Publishing in eCTD
  • Pricing and Reimbursement applications and consultancy
  • Regulatory review of artworks/packaging material
  • Regulatory review of promotional material
  • Regulatory Intelligence
  • Consultancy services on local regulatory provisions and requirements.
  • Notifications/Registrations and consultancy services for medical devices, food supplements, cosmetics and biocides
  • Training in Regulatory Affairs
Delivering Quality, Consistently

Quality Assurance

Our Quality Assurance department provides a clear path to maintaining compliance in the face of increasing regulatory scrutiny. Our team has dozens of 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.

We offer simplified reporting, easier audit preparation, improved document management and increased visibility across all processes to deliver quality management you can count on.

excelya FSP
Quality Assurance

What we deliver

Our Quality Assurance services include:

  • 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

How can we help support your trial?