Pharmaceuticals and Healthcare
Nepal’s pharmaceuticals, healthcare and life sciences sector is expanding rapidly, driven by regulatory reform, growing investment and rising demand for quality health services. Businesses face a complex network of laws, compliance obligations, licensing requirements and evolving global standards. We provide specialised legal and regulatory support for pharmaceutical companies, healthcare institutions, medical device manufacturers, clinical researchers and life science innovators.
Registration, Licensing and Compliance
We advise on the establishment of manufacturing plants, approvals from the Department of Drug Administration (DDA), and operational guidelines for hospitals and private clinics. Our services extend to regulatory documentation, product registration, drug manufacturing approvals, import and export permits and quality compliance standards, so clients can enter and expand in the market without compliance risk.
Corporate and Commercial
We draft and review distribution agreements, clinical trial contracts, supply arrangements, joint venture documents and technology transfer agreements, and advise on mergers and acquisitions, foreign direct investment in healthcare and strategic collaborations with international partners.
Ethics, Patient Safety and Disputes
With increasing emphasis on medical accountability and consumer rights, we help clients navigate malpractice claims, regulatory investigations, product liability issues and policy-related disputes. We also advise on the legal frameworks governing telemedicine, digital health platforms and emerging technologies in healthcare, and on data protection for patient information.
Policy and Capacity Building
We engage with regulatory bodies, industry associations and government to interpret evolving policy and contribute to sector reform, and we offer compliance audits, risk assessments and training to strengthen internal governance in healthcare organisations.