Regulatory and Compliance
At Tusay Holdings, compliance is not just a requirement—it’s a core business principle. We understand the complexity of navigating regulatory frameworks across food, pharmaceuticals, and veterinary categories, and we partner with our clients to ensure seamless market entry and operational efficiency.
As a preferred regulatory consultant and service provider for international brands entering Sri Lanka, we offer end-to-end solutions to manage risk, ensure transparency, and maintain full regulatory alignment.
Our Services
At Tusay Holdings, we believe compliance is not just a requirement—it’s a cornerstone of sustainable business. With the increasing complexity of local and international regulations, our dedicated Regulatory & Compliance division ensures your brand enters and operates in the Sri Lankan market with zero friction and maximum confidence. Our suite of services is designed to support both new market entrants and established players in maintaining full regulatory alignment and ethical business operations.
Full Regulatory Assessments for Market Readiness
Before launching a product in Sri Lanka, it is essential to evaluate its regulatory viability. We conduct comprehensive assessments to ensure your products meet all local legal, safety, and technical standards.
Services include:
- In-depth regulatory feasibility studies
- Product classification and category analysis
- Risk identification and mitigation planning
- Assessment of documentation gaps and required technical data
- Route-to-market strategy from a compliance lens
Product Registration and Submission Handling
We manage the entire product registration process, ensuring a smooth and timely path to market entry. Our experienced team liaises with national health and regulatory authorities on your behalf.
Support includes:
- Dossier preparation, formatting, and submission
- Handling of queries, objections, and resubmissions
- Coordination with Sri Lanka’s National Medicines Regulatory Authority (NMRA), Department of Animal Production & Health (for veterinary), and other relevant bodies
Monitoring the registration process until final approval is secured
Adhering to Sri lankan Food and Drug authority standards.
Tusay Holdings ensures all imported products comply fully with Sri Lanka’s health, food, and drug safety regulations. We stay up to date with all legislative changes and ensure that:
- Product labels, packaging, and inserts follow national guidelines
- Health and safety declarations are properly documented
- Imports follow the appropriate registration pathways
- Local testing, certifications, or verifications (if needed) are arranged
Ongoing Compliance Monitoring and Support
Compliance is not a one-time task—it’s an ongoing responsibility. We offer continuous monitoring and support to ensure that your products and operations stay compliant post-launch.
This includes:
- Renewal of licenses and product registrations
- Batch documentation and recalls (if required)
- Updates to packaging or formulation in line with regulation changes
- In-market surveillance and regulatory intelligence
Our proactive approach minimizes regulatory risks and ensures operational continuity.
Global Standard Compliance Alignment for Brand Partners
We understand that global brands have to comply with both international standards and local expectations. We help ensure alignment with:
- WHO GMP (Good Manufacturing Practice)
- ISO certifications
- HACCP, Codex Alimentarius, and other food safety standards
- Multinational corporate compliance frameworks
- Documentation harmonization between country of origin and Sri Lanka
Our compliance framework helps your brand maintain consistency, traceability, and accountability across all markets.
Legal and Document Advisory for Long-Term Licensing
For companies looking to establish a long-term commercial footprint in Sri Lanka, we provide tailored legal and documentation support. This includes:
- Guidance on setting up local representation, licensing agreements, and distribution rights
- Drafting and reviewing regulatory documentation for audits or inspections
- Ensuring legal protection of IP, trademarks, and import rights
- Support in contract compliance with local and international trade laws
We serve as your local compliance partner—helping you navigate the complexities so you can focus on brand growth and consumer trust.
Our focus is to provide peace of mind for our clients, ensuring their products meet all requirements and are ready to thrive in the local market.