Pharmaceutical and Cosmetics
We support local start-ups and sponsors in product development for drug, biologics or combination drug-device products.
For overseas manufacturers, we also provide drug product registration . In some cases, gap assessment would be conducted to understand the success rate before product registration in certain countries.
Our team has over 31 years of Global Regulatory experience.
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Biologics/NCE/Biosimilars Generic drugs, OTC, CTA, Health supplements / Food Supplements e.g. (Product Registrations/Renewals/Variation applications/PV management)
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Labelling/Packaging/Supply chain consultation
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Advertising and promotion guidelines consultancy
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Audits (including clinical trial QA and regulatory oversight) e.g. (QA supplier audits, GMP audits, GDP, GCP, GLP audits)
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Animal testing updates for cosmetics
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GMP, GCP, GDP and ISO related consultation
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Staff training on APAC Regulatory affairs
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Review label claims for health authority approval
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Import and wholesale license submission
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Holding product licences/ Name patient basis application
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Meeting health authorites and providing Compliance support
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Gap analysis (manufacturing sites and dossier)
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Post marketing surveillance
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Complaints handling
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Recall handling
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Webinars/ Regulatory Intelligence
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Regulatory Strategy Development
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