• Preparation and filing of submissions for prescription and non-prescription drugs, biologics, veterinary products & devices

• INDs, NDAs, ANDAs

• DMFs and PMFs in compliance with current standards;

• Establishment License Applications.

• Good Laboratory Practice and QA Set-up and management of research laboratories in compliance with industry and government guidelines.

• 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

• GMP HPFB, EMA, FDA and WHO, MOP audits

• GMP Gap analysis, As per FDA and HPFB, EMA, and WHO requirements