ASEAN Pharma Compliance Lawyer

I am scaling a Singapore-based pharmaceutical wholesale business into multiple ASEAN markets and need a Singapore-qualified lawyer who already understands the region’s life-sciences regime. The immediate mandate is regulatory compliance: mapping every licence, permit and notification my products will trigger, then guiding me through each authority’s process while keeping Singapore’s HSA rules and their ASEAN counterparts aligned. Your brief covers three pillars: • Licensing & permits – obtain or renew the wholesale dealer licences, GDP certificates and any product-specific approvals required in Singapore, Malaysia, Indonesia, Thailand and the Philippines. • Quality control & standards – review my current SOPs against WHO GDP guidelines and each country’s local adaptations; flag gaps and draft any supplementary documentation regulators may request. • Marketing & advertising – vet existing promotional copy, artwork and digital campaigns to be sure they meet each market’s restrictions on therapeutic claims, language, samples and HCP engagement. I will provide all existing SOPs, product dossiers, contracts and marketing assets. What I expect back is a concise regulatory roadmap by jurisdiction, completed application packs ready for signature, template wording for compliant marketing, and a short advisory memo summarising residual risks. If this first phase works smoothly, there will be follow-on work—contract drafting or even dispute support—so I value clear communication and commercially minded advice. Kindly outline your relevant ASEAN pharma experience, typical turnaround times and any in-house tools you use to track licence renewals.

Mã dự án: 40279866