Regulatory - Central Pharma

In addition to Central Pharma’s Quality Assurance process we provide regulatory consulting services to our clients in the pharmaceutical and nutraceutical sectors.

The changing regulatory environment can be a formidable prospect. There is accumulating pressure on resources, the regulatory authorities are applying increasing levels of examination regarding the release of new products onto the healthcare market and there is a greater dependency on the demonstration of value and efficiency.

Central Pharma has great depth of experience and can provide expert regulatory advice and services to develop strategies to effectively meet clients’ urgent and long-term global product development needs.

Central Pharma can help generate all the necessary regulatory documentation and drive these through the assesment and approval process to get your product to market.

Our Regulatory Consulting Services include:

  • Our Regulatory Consulting Services include:
  • Client GMP/GDP Gap Analysis and Audit (report)
  • Audits of API, manufacturing sites and laboratories
  • Quality Management System Review
  • Quality Manual Advice and Design
  • SOP Development and Creation
  • World Class Manufacturing Development and Application
  • Operational/Technical consultancy
  • Regulatory Strategy: Advice on EU and US legislation
  • Planning for GMP/GDP/GLP/GPP audits
  • Bioequivalence
  • Clinical Trial Monitoring Guidance and Advice
  • Common Technical Document Formatting
  • Drug Master File Guidance and Advice
  • Expert Statements for Product Licence or Batch Specific Variations
  • Leaflet User Testing
  • Mutual Recognition Procedure Applications
  • Periodic Safety Update Reports
  • Pharmacovigilance
  • Summary of Product Characteristics preparation
  • Advanced integration of track and trace systems
  • Serialisation process mapping and management
  • Stability and Shipping Studies
  • EU release testing
  • Qualified Person batch release to market