Project Management
Delivered for you
Studies & Testing
Review, investigation, planning of feasibility and pilot studies.
Certifications
Liaison and management of submissions with regulators for cGMP, GLP and GTP certifications
Approvals
Liaison and management of relevant approvals with civic and industry bodies for build and commissioning.
Export Oriented Solutions
EU, FDA, NPCB, TGA, OECD compliant Turnkey Build and Commissioning
With You. For You..
The primary challenge in such Projects is to achieve all of the project goals within the given constraints. The primary constraints usually are scope, time, quality and budget.
Projects stands in contrast with business as usual (or operations), which are repetitive, permanent, or semi-permanent functional activities to produce products. In practice, the management of such distinct production approaches requires the development of distinct technical skills and management strategies
Intran manages complete projects, right from its conceptualization to the delivery of the final product. In many cases we also work, on sub-sets of the overall project of our clients.
We Perfect The Delivery..
Over the years we have done projects that cover various scales, objective and mandates, including:
- Had built one of the earliest cCGMP/cGTP compliant facility for regenerative medicine with provision for an internationally accredited Quality Management System.
- Presently undertaking a turnkey project for the design, engineering construction and fit-out of a cGMP/cGTP compliant facility for the production of stem cell. This includes sizing of process systems to meet client’s requirement and improved cell processing techniques.
Client References
- NINPVB, MINSTRY OF HEALTH, SEPANG
- Celestial Lab (GMP/ GTP facility)
- Ryufu Food (Processing facility)
- Stemtech International (GMP/ GTP facility)
- Malaysian Palm Oil Board POME (recovery and concentration plant)
Network and Expertise
ITSB has extensive expertise and network in GMP/GTP compliant processes.
Experience
20+ successfully executed projects involving Bio-reactors, Bio-processing and Stem Cell R&D
Advisory and Execution
We don't just provide drawing room consultancy - we are on the site, building for (or with) you