Regulatory Affairs, Quality Assurance and Pharmaceutical Communications

About Elidex:

Elidex provides pharmaceutical solutions in regulatory and quality assurance through our in-house team of registered pharmacists who are familiar with the healthcare landscape. We have extensive experience in the Asia Pacific region, including ASEAN countries, Japan, Hong Kong, and Korea.

3 Service Cards:

    • License holding services (Singapore only)

    • Regulatory gap analysis and strategy development

    • Product registration and dossier preparation

    • Post-registration activities, including variations and renewals

    • Artwork management and regulatory labeling compliance

    • Establishing SOPs and Quality Management Systems (QMS) tailored to business needs

    • Compliance with Good Distribution Practice (GDP), Good Distribution Practice for Medical Devices (GDPMDS), and ISO 13485 standards

    • Handling customer complaints, deviations, and Corrective and Preventive Actions (CAPA)

    • Ensuring compliance with pharmacovigilance requirements

    • Medical communications and support for marketing materials

    • eCTD (Electronic Common Technical Document) regulatory writing and submission

    • Pharmaceutical design and visual communications, including artwork creation and branding support

    • Research & Development