Shalina has a team of registrations specialists responsible for maintaining pace with the dynamic regulatory guidelines of the countries where we operate.
We are committed to conforming to regulatory guidelines in every country we operate in. The registrations department is an integrated part of Shalina’s QA/QC departments in India and China.
The department is responsible for the timely submissions of registration dossiers in compliance to the current regulatory guidelines as per pre-defined goals for identified countries of interest.
This includes preparation of CTD and eCTD dossiers as per country requirements.
The registrations department also maintains Central and local FDA compliance with respect to manufacturing licenses / product permissions, WHO-GMP certification and free sale certificate /export certification.
We ensure that products manufactured and distributed by us, consistently meet predetermined quality specifications and our customer expectations.
We stand committed to strictly comply with current Good Manufacturing Practices (cGMP) in conformance with national and international standards.
We believe in continual improvement of our products and processes through training, innovation and active involvement of our employees.