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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.
Image by Louis Reed

  • Biologics/NCE/Biosimilars Generic drugs, OTC, CTA, Health supplements / Food Supplements e.g. (Product Registrations/Renewals/Variation applications/PV management)

  • Labelling/Packaging/Supply chain consultation

  • Advertising and promotion guidelines consultancy

  •  Audits (including clinical trial QA and regulatory oversight)        e.g. (QA supplier audits, GMP audits, GDP, GCP, GLP audits)

  • Animal testing updates for cosmetics

  • GMP, GCP, GDP and ISO related consultation

  • Staff training on APAC Regulatory affairs

  • Review label claims for health authority approval 

  • Import and wholesale license submission

  • Holding product licences/ Name patient basis application

  • Meeting health authorites and providing Compliance support

  • Gap analysis (manufacturing sites and dossier)

  • Post marketing surveillance

  • Complaints handling

  • Recall handling

  • Webinars/ Regulatory Intelligence

  • Regulatory Strategy Development

Image by Science in HD
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