Our Services
💼 Services – Regallion Pharma Solution
Regulatory Affairs
Navigating complex regulatory requirements can be challenging. Our Regulatory Affairs team provides end-to-end support for submissions, approvals, and compliance, ensuring your products meet both local and international standards.
Pharmacovigilance Support / Clinical Services
Patient safety is our top priority. We offer comprehensive pharmacovigilance and clinical services, including adverse event monitoring, reporting, risk management, and clinical trial support.
GMP Audits & Trainings
We conduct thorough GMP audits and provide professional training programs to ensure your organization meets global Good Manufacturing Practice standards.
eCTD / ACTD Publishing & Submission Services
Our experts handle electronic Common Technical Document (eCTD) and ASEAN CTD (ACTD) publishing and submissions, delivering accurate, fully compliant dossiers to regulatory authorities.
Intellectual Property Rights & Patent
Protecting your innovations is critical in the pharmaceutical industry. We provide services for intellectual property management and patent support.
Gap Analysis / Queries
Our team conducts detailed gap analyses to identify compliance gaps, potential regulatory risks, and operational inefficiencies, providing timely responses to regulatory queries.
Registration of Products / MA Holding Services
We offer end-to-end support for product registration and market authorization (MA) holding services, helping your products gain regulatory approval and reach markets faster.