Regulatory
Preparation and maintenance of product specific dossiers and authorisations:

• Active Substance Master Files
• Certificates of Suitability (CEP)
• Investigational Medicinal Product Dossiers
• Marketing Authorisation Applications
• Variations
• Licence Renewals

Support for companies in attaining and maintaining facility licences:

• Manufacturer’s / Importer’s Licences
• Specials Licences
• Wholesale Dealer Licences

Quality
Process based services to facilitate and maintain GMP accreditation:

• Quality GMP audits
• GMP assessment and improvement programmes
• EU Qualified Person support
• Preparation and review of Quality Management Systems
• GMP Training

Technical
Services to assist companies in sourcing new suppliers and transferring production:

• Product and manufacturer identification
• Technical transfer
• Validation