Stem Cell Facility Consultants (GMP)
We support companies poised to make early inroads into the burgeoning Stem cell & Regenerative Therapy industry to improve their business, profile, products, and processes.
Who can benefit from our Stem cell consultancy services?
- Companies new to the sector (e.g., pharma’s, biotech, investor, VC`s, etc.) we help you understand the stem cell industry and opportunities for your participation.
- Companies who are already in the Stem cell sector, we help you to position the company and/or products better to capture more market share.
- Mature companies, who eye the attention of potential investigators, collaborators, licensees, partners, investors, etc. or helping to navigate the technical intricacies of product and process development can also be benefited by our Stem cell expertise.
What are our Stem cells and Regenerative medicine Services?
- Consultation and Regulatory Advice for Startups in Stem cell and Regenerative medicine field.
The decision to initiate a cellular therapy or regenerative medicine program requires planning at both the institutional and government level. Our team of professional staff and advisors are experienced in this process, and will assist you in the planning and implementation of every step.
- Designing the Plan & Outlay of Clean rooms
The design of a Stem cell processing lab is unique and special in several ways. We can guide you in constructing the `outer shell’ building or choosing the pre constructed building as per the existing norms and guidelines. Our expert team will facilitate the designing the blueprint of the Stem cell processing labs ,clean rooms, cryo-banks etc.
- Equipment’s specification and their Validation Procedures
We can guide you in selecting the equipment’s, machinery and various tools required in the stem cell processing labs. We facilitate the validation and optimization of the equipment’s too.
- Stem cell processing SOP`s compliant with cGMP & cGTP standards
It should be noted that processing cellular based therapies under cGMP will require sound scientific methods which are novel, validated, and well documented. We have experience optimizing, implementing, and validating leading stem cell harvest, cell processing/expansion, environmental control, and cryopreservation technologies to ensure that you reach your homogeneity and stability goals required under cGMP/cGTP regulations.
- Total Turnkey project
We offer turn-key packages for every prospective client , of stem cell processing. Whether your desire is to be a fully complaint cGMP cell processing facility or simply a small scale GLP start-up research cell lab, we can handle the project. We conceive and visualize your project in its entirety, including the level of regulatory compliance required. We will outlay the entire plan and course of action , which is all inclusive of the required technology and equipment, optimal procedures and standard operating procedures (SOP`s), validation of all equipment / facility and many other day to day practical issues , which will terminate in the realization of your dream of building a state-of-the-art world class facility.
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