Product Engineering Services & Solutions blending Applied Sciences with Technologies
Life Sciences & Pharma
The Life Sciences and Pharmaceutical works in a highly regulated environment. The regulations demand stringent quality standards that can be achieved by using the innovation in technology.
BAT just does that. BAT provides technological solutions to the problems in Life Sciences and Pharmaceutical Industry.
Computer System Validation
As per the US FDA guidelines, third party Computer System Validation (CSV) is preferred over in-house CSV.
BAT has more than a decade of experience in the software development and testing applications in the applied sciences domain. BAT also has knowledge of associated regulatory requirements. BAT has performed CSV for many pharmaceutical organization scoping validation planning, scripting and execution (IQ, OQ and PQ).
Analytical Method Development and Validation
BAT team has solid experience in Method development, Method validation and Sample Analysis for the different industrial sectors like Pharma, CRO’s, Health-care, Food Safety etc.
BAT laboratory is well equipped with all the necessary instruments like LC MSMS, LC TOFMS, UPLC, HPLC, UV-VIS, PCR, etc. with wet lab.
BAT has been providing the end to end solutions from Sample preparation till the Analysis methods. All the laboratory processes are based on the standard industrial guidelines like GLP and US FDA.
Bespoke Application Development
BAT offers software development and testing services in a wide range of life sciences areas and applications like medical devices, medical imaging, Genomics, Proteomics, Clinical Trials, BioStorage solutions and so on.
BAT facilitates organizations achieve their “Go To Market” strategy by developing a commercial product from the customers research data / service.
We are well versed with data analytics and reporting and have supported our customers with data presentation, processing and reporting capabilities within their applications. BAT has provided solutions for applications involving micro plate data acquisition, analysis, graphing and reporting.
BAT has experience working in regulatory environments like “IEC 62304 (Medical device software – Software life cycle processes)”, ISO 13485 (Medical devices — Quality management systems — Requirements for regulatory purposes), 21 CFR Part 11 (Electronic Records and Electronic Signatures).
Success Stories
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“The BAT team are very professional, we have good communication and engagement with the team who are able to demonstrate a strong mix of life science application and software technical knowledge. This balance has delivered value in practice, allowing teams to get up to speed with our projects efficiently, and deliver on commitments without the need for constant supervision.”
Software Quality Assurance Brooks Life Science
“The partnership with BAT has been a contributing factor in achieving the business goals for Waters MS division. We are pleased with the commitment and dedication exhibited by BAT practitioners and management. BAT has a team with strong domain and software life cycle expertise. BAT can be proud of its vision statement of solutions that make a difference”
Waters The Sciences of What's Possible.
“Shimadzu engaged Bio-Analytical Technologies (BAT) for an important addition across its software products suite. BAT designed and developed the application where we found that they are reliable service provider who treated Shimadzu as a valued customer. BAT delivered the solution with utmost flexibility yet as planned, on schedule which really made a difference to Shimadzu. At Shimadzu we definitely would consider BAT as a long term partner.”
General Manager Research & Development