Basic info
Industry
pharmaceutical manufacturing
Sectors
Procedure management – centralised
Common technical document compilation; Modules 1-5 in ICH regions and beyond
Medical Device
Labelling including User Testing
Agency Meetings including Scientific Advice
Paediatric Investigational Plans (PIPs)
Pharmaceutical
Regulatory Strategies (Global)
Clinical Trial Applications (CTAs)
mutual recognition
Orphan drugs designations
B2B
Post approval Variations and Renewals
decentralised
New product development; formulation and Country regulatory feasibility surveys
quality assurance
special manufacturing requirements
Life Cycle maintenance - International business expansion
Consulting
national
Project Management (Global)
Manufacturing / Production; tech transfers
OTCs including switches
Date founded
2003