CONSULTING
Consulting on local legislation and regulatory specifics, development of regulatory strategy
REGULATORY AFFAIRS
Approval of your product for further commercialization, access to all desired territories
LIFECYCLE MANAGEMENT
Obtaining marketing authorization, managing modifications, and ensuring customer communication
PHARMACOVIGILANCE, SAFETY & QUALITY MONITORING
Detection, assessment, and prevention of adverse effects or any other drug-related issues
INSPECTION OF MANUFACTURING SITES AND FACILITIES
Organization and support of inspections by regional accredited bodies at manufacturing sites and quality-responsible offices
TRAINING & WORKSHOPS FOR STAFF AND SPECIALISTS
Standard programs for open trainings and tailored programs for corporate clients on specific topics