A client focused global consultancy company, based on +30 years regulatory body experience and GxP global industry expertise, including delivery of successful multiple approvals by EU/ US-FDA / PMDA / ANVISA / HC / TGA / MoIT / GCC.

Main areas of expertise: Quality Systems, Validation, sterile manufacturing (aseptic filling, terminal sterilization, lyophilization), SODs manufacturing, API manufacturing, IPC/Release/Stability testing (chemical and micro), Environmental and personnel monitoring, GMP equipment, facilities and critical utilities qualification, GxP audits, data integrity, project management, inspection readiness and remediation 

Our emphasis is to always deliver on-time customized solutions and outstanding affordable services in full compliance with all relevant regulations.