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We have a highly skilled team of regulatory affairs specialists who are well versed with regulatory policies and procedures around the world. They have a wealth of experience in the timely filing of dossiers as well as handling regulatory queries from both authorities and customers.
Weldew regulatory team is well experienced in developing dossiers as per CTD/ECTD formats for such complex products. Weldew has a distinguished regulatory department specifically for DCGI & FSSAI approvals. The department in co-ordination New Product Development Team work towards the needs and wants of the business partners.The Bio-Equivalence studies & Clinical Trials are also arranged by the said department as and when asked by DCGI.
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