Three pillars covering the full product lifecycle

Strategic Gap Analysis & Pre-Submission Audits

We execute precision-driven pre-submission simulations to identify dossier deficiencies and regulatory risks, ensuring your technical dossier (ACTD/ICH-CTD) is compliant and review-ready prior to Thai FDA submission.

End-to-End Regulatory Lifecycle Management

Comprehensive regulatory management spanning dossier preparation, initial registrations, post-approval variations, and advertisement approvals across broadcast, print, and digital media for pharmaceuticals, medical devices, food/dietary supplements, herbal products, and cosmetics.

GMP Inspection & Facility Licensing Consultancy

Expert consultancy for Thai FDA and PIC/S GMP inspections, including readiness assessments, mock audits, corrective and preventive action (CAPA) planning, and onsite support.

Comprehensive Facility Licensing (Manufacturing / Importation / Storage)

Pharmaceuticals & medical devices — manufacturing plants, import entities and specialised warehouses · Food, supplements & cosmetics — structural compliance planning and licence acquisition to national hygienic standards · Hazardous substances (medical use) — clearance and licensing for manufacture, import, storage and commercial possession.

Our Product Registration Portfolios

Pharmaceuticals (innovative drugs, biologics, generics, biosimilars) · Medical devices across all risk classifications · Food & dietary supplements · Cosmetics · Herbal products · Hazardous substances.

Accelerated Launch

Products can be deployed under our existing licences and regulatory infrastructure, enabling faster market entry.

Asset-Light Entry

Market access is achieved without the cost and complexity of establishing a physical office or corporate entity in Thailand.

Compliance Management

We assume full regulatory responsibility, ensuring continuous compliance with Thai FDA standards, while the innovator retains brand ownership and control.

Operational Flexibility

This model allows companies to scale operations or test market potential with minimal long-term commitment.

Clinical Document Preparation

Protocols, Standard Operating Procedures (SOPs) and manuscripts, prepared and quality-checked.

Regulatory Submissions

Submissions to both the Institutional Review Board / Ethics Committee (IRB/EC) and the Thai FDA.

Clinical Site Management

Study feasibility, site initiation, and ongoing clinical monitoring.