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.
-
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
