Preparation and Handling of USFDA, MHRA, EU GMP Portugal, Ukraine, Brazil, Tanzania, Kenya, Ethiopia, and Yemen Bela rush, Kazakhstan, WHO-GMP, Schedule M, ISO9001, NABL, and EIC/EIA Audit. Preparation, Training & Implementation of SOPs, VMP, SMF, EMP, QM, PV, AMV, Water Validation, AHU Validation, and RA documents CTD, DMF, ANDA, NDA, APQR as per PIC, USFDA, ICH. Vendor Audit.

01. Starting from URS Initiation for Facility, Layout of facility as per Compliance,URS of Utility, Equipment/Instrument, Qualification (DQ/FAT/SAT/PIQ/IQ/OQ/PQ). Training of Respective Staff on above document for further Preparation and Implementation to smooth audit clearance.

02.Training of staff to How to Prepare and Handle Audit Interpedently so that individual person can answer during audit which is now expectation of auditor.

03.Training of Staff for the preparation and Implementation of Quality Manual, Validation Master Plan, Environmental monitoring plan, Site master file, Process validation, Analytical method validation, Annual Product Review as per WHO, Schedule M, European guideline, PIC, USFDA, ICH Guideline, Total Management of Stability study as per ICH Guideline

04. Training of Staff for the preparation and Implementation of SOPs for all department.

05.Training of Staff how to prepare QMS documents, Their Implementation and how to explain to Auditor.

06. Training to all the employees GMP and GLP related aspects for improving the competency of the individuals.

07.Therd party audit of supply and their Compliance review of audit Observation.

08.Preparation of compliance for audit observation.

09.Trained the staff How to do Audit preparation.

10.Providing different type of Documents.