The wide experience of our team members allows us to offer our clients with a personalised lean Regulatory Affairs solution, from complex projects to simple submission supports. This includes support in the following fields:

Redaction (chemical and biological medicinal products):

• CMC / Quality (Modules 2.3 and 3)
• (Pre) Clinical (Modules 2.4 to 2.7)
• Administrative (Module 1)
• Active Substance Master File (ASMF/DMF)
• Certificate of Suitability (CEP)
• Investigational Medicinal Product Dossier (IMPD)

Management and submission:

• European procedures: centralised (CP), mutual recognition (MRP), decentralised (DCP) and national
• Non-European procedures: experience in Africa, Middle-East and Asia
• Variations
• Renewals
• Clinical trials (including amendments)

Support:

• Product information: QRD formatting and labelling maintenance
• Regulatory compliance maintenance / Gap analysis & remediation
• Change controls evaluation
• Acting as contact person for Belgium, France, Luxembourg, The Netherlands and United Kingdom Health Authorities
• Project Management
• Procedures redaction / review
• Coaching and training
• Tracking database implementation / management
• Electronic archives implementation / management

Regulatory Intelligence:

We are continuously surveilling the local and regional legislations (regulations, directives and guidelines) in order to be able to provide our clients with the best regulatory strategic advice in accordance with the current guidelines.