Preparation and filing of submissions for
prescription and non-prescription drugs, biologics, veterinary products &
INDs, NDAs, ANDAs
DMFs and PMFs in compliance with current
Establishment License Applications.
Good Laboratory Practice and QA Set-up and
management of research laboratories in compliance with industry and government
Will Assume complete quality control function
for companies without QC/QA :
-.Release products on-time for market.
-·Comprehensive accurate reporting.
-Problem solving / recommendations.
-Complete product traceability.
-Complete SOPs /SOP manual
GMP audits, As per FDA and HPFB, EMA and WHO requirements
vendor/supplier audits, policy procedure review and development