We help our customers with highly skilled and well-trained world class resource to help their business transformation and growth. Our primary focus is Pharmaceutical GMP and cGMP facilities including GMP and QC labs. Our service include but not limited to :
- Method Development & Validation
- Data Integrity & CSV services
- Quality Control & Failure Analysis
Method Validation
Beyond method development, our skilled method validation chemists can verify existing methods to help ensure approval of regulatory submissions. Our team can also improve upon existing methods by identifying gaps and proposing a detailed remediation plan. Our experienced staff can develop methods for even the most complex formulations within your timeframe.
Data Integrity & CSV
We provide lab data integrity verification and validation services. We can provide excellent resource who can guide you with the ALCOA + DI concept and help to establish required DI controls. We have full service CSV team to help you in validating any system or tolls that touches your GXP data.
Quality Control & Failure Analysis
Our experienced consultants can help you in QC, QA verification of parameters as are linearity, accuracy, robustness, stability, specificity, repeatability, precision for the method in the laboratory condition for the samples. They have expensive experience in lab instrument, tools and system like HPLC, Empower, GC etc.
