iPharmatec Solutions is a fast growing international consultancy offering GMP compliance, qualification & validation, regulatory and engineering consulting services to pharmaceutical, bio-pharmaceutical and medical device industries.

Our aim is to be your integrated compliance partners by helping you design, build and operate manufacturing facilities that will fully comply with international Good Manufacturing Practice (GMP) regulations such as US FDA, EU EMA, MHRA, BSG Germany, TGA Australia, NewZealand MedSafe, Singaporean HAS, Korean FDA, HPFBI Canada, MCC South Africa and WHO Geneva.

We have been serving our clients in the Asia-Pacific, GCC, MENA (Middle East and North Africa) and European Union region for over 15 years from our global offices.

Our team of experts work with pharmaceutical companies to ensure that manufacturing facilities, processes, equipment and quality management systems are compliant with international regulatory standards e.g. USFDA, ICH, PIC/S, WHO, TGA, ISO and other local standards.

We inspect pharmaceutical companies to find the GMP gaps through system based approach and help to implement and improve GMP compliance and process efficiencies.

Our experts review and implement structured quality management system for production, quality control, warehouse and quality assurance system. They also train personnel from production, quality control, quality assurance, warehouse and engineering departments to implement and follow GMP compliance.

We are integrated compliance partners for our clients. We guarantee your compliance to international GMP standards by following system based approach and structured onsite support during GMP implementation.

• Risk based qualification / validation
• Full QMS documentation
• Onsite validation assistance

• One stop shop for GMP compliance
• Cost effective GMP compliance
• High standard quality documentation