At RegTech India Solutions, we specialize in assisting pharmaceutical manufacturers and exporters with seamless Product Registration and Marketing Authorization (MA) Holding Services in complex and emerging global markets. Our extensive regulatory expertise and trusted local partnerships ensure timely and compliant product approvals.
Countries we served:
Philippines 
Navigating FDA Philippines' requirements can be challenging. We offer end-to-end registration services including dossier compilation (as per ACTD/CTD format), submission support, and liaison with local authorized agents to expedite approval timelines.
Peru 
& Colombia 
With evolving regulations from DIGEMID (Peru) and INVIMA (Colombia), we provide customized registration strategies for both Prescription (Rx), OTC products & Nutra Supplement. We ensure dossier preparation in Spanish, legal representation, and post-submission support.
Ghana
Our MA holding services in Ghana, through our reliable in-country partners, ensure smooth coordination with the FDA Ghana. We manage product registration, local representation, and GMP compliance documentation.
Azerbaijan
We support product registration in Azerbaijan in alignment with the Ministry of Health’s regulatory framework. From dossier preparation to handling local representation and translation needs, we ensure regulatory readiness for the CIS region.
Equador
We support product registration in Ecuador navigating the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) regulations requires expert knowledge and accurate documentation to ensure timely approvals. From dossier preparation to handling local representation and translation needs, we ensure regulatory