Pharmaceutical Project management:
The services that we offer through pharmaceutical Project management are as followed:
Conceptualization
Engineering services
Equipment and processing specification
Technical advisory services
Management services
Regulatory services
We readily offer services to set up the plant or section as per WHO GMP/MHRA/USFDA/ANVISA/NAFDAC etc… and many of the regulatory authorities.
We also offer Contractual Analytical Services:
Development of specification and method of analysis
Structural identification and quantization of impurities and polymorphism using techniques such as LC/MS/MS and X-Ray Diffraction
Separation and purification of impurities
Method development, optimization and validation
Structural identification of medical specimen such as kidney stones, gall bladder stone
Pharmaceuticals Industry
Food Industry
Validation and Support Activities
Validation Master Plan (VMP)
Qualification Protocols like IQ, OQ, IOQ, PQ
Validation Protocol for Utility, Systems, Processes, Cleaning, Analytical Method
Validation Summary Reports
Training
Actual qualification and validation support for Equipments, Systems, Processes
Techniques For Sample Analysis
Physicochemical attributes
Latest Technique Viz. UV, IR, HPLC, GC, LC/MS/MS, XRD
Purification and preparation of working standard
Certification of analytical reference standards via full chemical analysis
Microbiology Studies
Microbial Count
Sterility Testing
Endotoxin Testing
Identification of microbes up to genus and species level
Isolation, cultivation and storage of pure cultures
Verification counting of Biological indicators
Microbiological assays
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