Biopharmax is a global leading design and construction group specializing in the Biopharmaceutical market segment. We have provided services to the leading pharmaceutical companies in Europe, US, Southeast Asia, China, and India. Biopharmax undertakes projects from URS/concept stage through implementation to successful validation. We provide the following services as part of a dedicated project or on an individual basis: • Turnkey Projects from Design to Supply, Installation, Commissioning and Qualification (API, Formulation, Nutraceuticals ) • Conceptual, Basic and Detail Engineering -Process, Utilities, HVAC & Clean Room, Production Subsystems, Electrical, and Instrumentation & Control • Process Skids and System Expertise-CIP/SIP, Fermentation, PuW/WFI/Pure Steam • cGMP Gap Analysis and Gap Closure • Project Management consultancy (PMC) services • Validation – C&Q, CSV- DCS, PLC & SCADA for all Control Systems • Technology Sourcing • Compliance: US FDA, EMA, MHRA, TGA, WHO, ICH cGMP, • We are ISO 9000-2015 certified. Our experience in the design and implementation of Biopharmaceutical high-tech facilities coupled with a unique project design-build approach ensures our compliance with these requirements. Biopharmax is committed to maintaining the strictest standards and complying with the latest cGMP requirement per global and local authorities (FDA, EMEA, SFDA, Indian cGMP, local MoH, etc.).
