LCMS, GCMS, DSC, TGA, XRD, AAS, ICP etc. analyses currently outsourced to certified laboratories.
All Analytical Instruments and Stability Chambers are fully qualified.
Majority of the analytical instruments are 21CFR part 11 compliant.
Analytical servies offered:
Quality Certification and Clearance
Analytical Method Development
Analytical Method Validation as per ICH guideline
Stability Studies as per ICH guideline
Product Characterization
Impurity Profiling
Our analytical Labs cooperate with our R&D Department to develop and validate new analytical methods.Tests according Pharmacopoeias (EP, USP, JP), in house methods and / or on the basis of customer requests are performed.
Pharmaessense has extensive experience in Analytical Method Development, Method validation and Methods transfer. Numerous analytical methods has been developed, validated and transferred successfully.
We are GLP compliant and our Quality System is focused on the "continuous improvement" philosophy.
We welcome all our customers to audit us and verify our compliance with cGLP.