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:
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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
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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
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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