Consulting in the process of establishing quality management system according to national and international standards (ISO 9001, ISO 14001, ISO 18001, cGMP)

• Development of finished dosageforms and reformulation of the existing formulas (solids, semisolids and liquids; Rx and OTC drugs, medical devices, dietary supplements, cosmetics),
• Analytical method development, method upgrades and method validation
• In vitro testing
• Technology transfer and analytical method transfer
• Stability tests in accordance with ICH guidelines
• Packaging technology and primary packaging material proposals

• Manufacturing and packaging of bulk products
• Serialisation
• Validation of chambers (air condition, fridges, autoclaves)
• Preparation of specifications of user requests and risk analysis for procurement of manufacturing equipment, measuring instruments etc.
• Evaluation of offers, installation and qualification of equipment, measuring instruments etc.
• Preparation of patterns for
  blister machines

• Regulatory Strategy, Guidance & Support
• Registration dossier development and upgrade (Module 1- Module 5)
• Advice on national or EU regulation for drugs and medical devices
• Compilation and submission of Marketing Authorisation applications /renewal applications to Regulatory Authorities
• Medical writing and updating (labelling, leaflets and SmPC)Regulatory compliance for food supplements and cosmetics
• Pharmacovigilance
• Preparation and submissions for regulatory approvals for clinical studies
• Review (regulatory requirements) and submission of promotional materials to Regulatory Authorities