Drugs
We help local start-ups 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
  • Holding product licences/ Name patient basis application/ Own brand manufacture

  • Health authority negotiations/Compliance support

  • Gap analysis (manufacturing sites and dossier)

  • Post marketing surveillance

  • New Product Introduction process SOP

  • Complaints handling

  • Recall handling

  • Webinars/ Regulatory Intelligence

  • Regulatory Strategy Development

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

  • Labelling/Packaging/Supply chain consultation

  • Advertising and promotion guidelines consultancy

  •  Audits (including clinical trial QA and reg oversight) (QA supplier audits, GMP audits, GDP, GCP, GLP audits (Distributors, Health authorities))

  • Animal testing updates for cosmetics

  • ISO 9001 set up, GMP, GCP, GDP set up consultation

  • Staff training on APAC Regulatory

  • Label claims for health authority approval 

  • Import and wholesale licences submission

Image by Science in HD