Regulatory Affairs & Documentation
Our expert team of Regulatory Affairs professionals has deep knowledge of global policies, documentation standards, and filing procedures. They bring valuable experience in managing timely dossier submissions and addressing queries from both regulatory bodies and business partners.
Weldew’s regulatory division excels in developing dossiers for complex pharmaceutical products in globally accepted formats such as CTD and eCTD. We also ensure full compliance for DCGI and FSSAI approvals, enabling smooth product registrations.
Our regulatory experts closely collaborate with the New Product Development (NPD) team to support faster market entry. We also manage Bio-Equivalence studies and Clinical Trials as mandated by DCGI.