Pharmaceutical

We provide comprehensive legal support to pharmaceutical companies at every stage of the product lifecycle. Our services include assisting with regulatory approvals, securing import and distribution licenses, advising on clinical trials and pharmacovigilance compliance, and ensuring adherence to advertising and promotional restrictions. We also support clients in negotiating licensing agreements, handling supply chain and distribution contracts, and managing disputes related to product liability, IP infringement, and compliance violations.
By partnering with us, pharmaceutical companies can ensure regulatory compliance, mitigate legal risks, and bring safe and effective products to market efficiently, while protecting their business interests and maintaining a strong competitive position in Vietnam’s pharmaceutical industry.

Infrastructure and Facility Development

Infrastructure and Facility Development in the pharmaceutical and medical devices sector involves establishing compliant manufacturing plants, laboratories, and distribution centers that meet regulatory standards in Vietnam. These facilities must adhere to stringent guidelines for Good Manufacturing Practices (GMP), Good Storage Practices (GSP), Good Distribution Practices (GDP), and Good Pharmacy Practices (GPP) as well as requirements for environmental impact assessments and construction permits.

We provide comprehensive legal support for the development of pharmaceutical and medical device facilities, assisting clients with regulatory approvals, land use rights, and construction licensing. Our services include advising on project structuring, drafting and negotiating contracts, and ensuring compliance with environmental and safety regulations. We also assist clients in navigating inspections and certifications to secure operational permits.

Regulatory Compliance

In Vietnam, companies must comply with regulations related to product registration, import and distribution licenses, labeling, clinical trials, and post-market surveillance. Failure to adhere to these regulations can result in fines, product recalls, or suspension of operations.

We provide comprehensive legal support to help clients navigate regulatory compliance requirements. We advise clients on compliance with Good Manufacturing Practices (GMP), Good Storage Practices (GSP), Good Distribution Practices (GDP), Good Pharmacy Practices (GPP), and Good Clinical Practices (GCP). Additionally, we support clients during regulatory inspections and audits and assist in managing compliance issues related to advertising, labeling, and product recalls.

Clinical Trials and Research

We provide comprehensive legal support for clinical trials and research, assisting clients in obtaining the necessary approvals, drafting and reviewing clinical trial agreements, and ensuring compliance with GCP and ethical guidelines. Our services include advising on regulatory submissions, managing contracts with research institutions and investigators, and navigating potential legal issues related to trial conduct and patient rights. We also assist clients in responding to audits and addressing non-compliance findings.

Product Approvals and Market Access

We provide comprehensive legal support for obtaining product approvals and facilitating market access. Our services include preparing and submitting product registration dossiers, securing marketing authorizations, and advising on compliance with regulatory requirements for imports and distribution. We assist clients in navigating the review process, addressing regulatory queries, and managing post-approval obligations, such as product labeling, reporting, and renewals.

Licensing and Partnerships

Licensing and Partnerships play a vital role in the pharmaceutical and medical devices sector, enabling companies to expand their market presence through collaboration, distribution agreements, and technology transfers. In Vietnam, licensing and partnership agreements must comply with regulatory requirements related to intellectual property rights, marketing authorizations, and competition laws to ensure legally sound and mutually beneficial arrangements.

We provide comprehensive legal support in structuring and negotiating licensing and partnership agreements. Our services include drafting and reviewing distribution, co-marketing, and technology transfer agreements, ensuring compliance with regulatory and intellectual property frameworks. We also assist clients in securing the necessary approvals for licensing agreements and navigating joint ventures or strategic alliances to expand their operations in Vietnam.

Intellectual Property Protection

We provide comprehensive legal support for IP protection, assisting clients with patent and trademark registration, monitoring for potential infringements, and pursuing enforcement actions, such as cease-and-desist letters and litigation. Our services also include advising on IP-related clauses in licensing, distribution, and co-development agreements to ensure ownership rights are preserved. Additionally, we help clients secure regulatory exclusivity for approved pharmaceutical products.

Advertising and Marketing Compliance

We provide comprehensive legal support to ensure advertising and marketing compliance. Our services include reviewing and drafting advertising materials, advising on permissible claims, and ensuring that promotional activities comply with regulations issued by the Ministry of Health. We also assist clients in obtaining necessary approvals for advertisements, managing regulatory audits, and addressing disputes related to misleading or unauthorized promotions.

Product Liability and Risk Management

We provide comprehensive legal support in product liability and risk management, assisting clients in developing and implementing risk mitigation strategies. Our services include advising on product safety and quality control measures, drafting and reviewing disclaimers and warranties, and ensuring compliance with reporting obligations for adverse events. We also assist clients in managing product recalls, handling regulatory investigations, and defending against product liability claims in administrative or judicial proceedings.

Supply Chain and Distribution

We provide comprehensive legal support for supply chain and distribution operations, assisting clients with drafting and negotiating distribution, supply, and logistics agreements. Our services include advising on regulatory compliance related to storage and transportation, securing import and distribution licenses, and ensuring adherence to product labeling and traceability requirements. We also support clients in managing disputes with distributors, suppliers, or logistics providers.

Pricing and Tender

Pricing and Tender processes in the healthcare, pharmaceutical, and medical device sectors in Vietnam are subject to strict regulations to ensure transparency, fair competition, and affordability. Government tenders, particularly for public hospitals and healthcare facilities, often impose specific pricing requirements and restrictions on bids. Businesses must adhere to regulations related to price registration, product listing, and price stabilization measures. Failure to comply can result in disqualification, penalties, or reputational damage.

We provide comprehensive legal support for pricing and tender processes, assisting clients in preparing competitive and compliant bid submissions. Our services include advising on price registration and disclosure requirements, reviewing bid documents, and ensuring compliance with tender regulations and procurement laws. We also assist clients in handling post-tender negotiations, managing disputes related to bid evaluations, and responding to regulatory audits or pricing reviews.

Key Contacts

Sign up with your email below to stay informed.

Pharmaceutical

Duong Thanh Long

Nguyen Quoc Phong

Bui Thi Ha

Dao Phuong Hanh

Tran Thi Huong

Luong Thi Oanh

Tran Sy Quang