Southeast Asia (SEA) nations are moving towards harmonization via the establishment of ASEAN Common Technical Dossier (ACTD) for quality, safety, efficacy, administrative data and product information by end 2008.
However, within the generalized framework, separate evaluation and assorted ever-changing requirements for each country is expected, thus leading to a lengthy and tedious registration process.
At RX Pharma PL, our regulatory affairs team provides comprehensive regulatory services and solutions to enable our clients to navigate through the unique regulatory climate and take your product via the shortest route into the emerging markets.
• New Chemical Entities (NCE)
• Generic drugs
• OTC products
• Traditional medicines
• Health supplements
• Medical devices
We are looking into providing regulatory services in two major niches:
• Multi-national pharmaceutical company with own regulatory team
•• Unfamiliar with regulatory guidelines in SEA and require our experience.
•• Sudden surge in regulatory matter demands
• Small and medium pharmaceutical company
•• Keen on developing presence in SEA and require regulatory consultancy
•• Limited resources to support in-house regulatory needs