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