Generation of protocol execution of validation studies and reviews.
Regulatory Affairs
Laboratory Audits
And Reviews
Technical audits based on various guidelines and requirements.
BioanalyticalMethod Developments And Services
Development of analytical methods for estimation of active drugs/metabolites from human plasma and biological fluids.
Preparation Of
European DMF's And Application For Certificates Of Suitability
Complete analytical work required for DMF/Certificate of suitability including Impurity profiling, forced degradation studies, Stability studies, etc.
Regulatory Consultancy And Strategic Advice
Expert Report Writing
Independent expert comments on the DMF/Certificate of suitability.
Interaction With Regulatory Agencies
QA Systems &
Documentation
Developing and Providing QA systems and documentation for the total Quality assurance field of company.
DMF Compilation and Consultancy
On project related basis.
Credentials
Approval for carrying out test in drugs/cosmetics and raw materials used in their manufacture on behalf of licencee for manufacture for sale of drugs/cosmeticsApproval is granted by The Food and Drug Administration, Maharashtra State, India, in December 2004.
The quality systems of the laboratory have been certified to ISO 9001: 2000 standards by Q. A. International certification. U.K. 19.10.2005.
The analytical laboratory is approved by US FDA.
Approved by MCC (South Africa) and WHO (Geneva).
BA/BE projects for ANDA and NDA filings by the sponsor has been approved by sponsor.
