Required Certificates

Certificate of Pharmaceutical Product

A Certificate of Pharmaceutical Product (CPP) is mandatory for registering APIs in Vietnam. It certifies that the ingredient is authorized for sale in its country of origin and confirms its compliance with Good Manufacturing Practices (GMP). Alau Vietnam coordinates with your national regulatory authority to secure, legalize, and translate the CPP in accordance with Vietnamese regulations. This ensures your product’s legitimacy is recognized during the registration process, expediting approval for import and use in Vietnam.

Product Quality Standards Document

Vietnamese authorities require a Product Quality Standards Document that defines the API’s identity, purity, potency, and safety parameters. This document must align with international pharmacopoeias or validated in-house standards recognized by regulators. Alau Vietnam works closely with your technical team to adapt and present these specifications in a format compliant with Vietnamese guidelines, ensuring the product’s quality profile meets both domestic and international standards.

Product Testing Methods Document

To register APIs in Vietnam, manufacturers must submit validated testing methods used to verify product quality and consistency. This includes analytical techniques for identity, assay, impurity profiles, and stability. Alau Vietnam assists in compiling and formatting these testing protocols according to Vietnamese requirements, ensuring they are clear, reproducible, and verifiable by local quality control laboratories.

Support Documents

Customs Declaration

Once approved for import, every shipment of APIs must undergo customs clearance. This process includes proper HS code classification, veterinary or pharmaceutical import licensing, and coordination with border inspection authorities. Alau Vietnam handles the full Customs Declaration process, ensuring all documentation is complete and compliant, reducing clearance times, and helping you maintain uninterrupted supply to your Vietnamese partners.

Product Labels, Packages

Even though APIs are primarily imported for manufacturing rather than direct sale, Vietnamese regulations require compliant labeling and packaging. This includes manufacturer details, batch numbers, production dates, expiration dates, and storage conditions in both English and Vietnamese. Alau Vietnam ensures your product labels and packages meet legal requirements and reflect accurate, standardized information, supporting both regulatory compliance and quality assurance.

Market Entry Consulting

Key Market Segments

Key Market Indicators

Market Entry Strategies

Risk Planning

Key Services

Support Services

Registration Services

Benefits From Alau

Compliance Services

GMP, GACP, Practices

Audit Supports

Extras From Alau

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Accounting

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Animal Health Industry

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Bookkeeping

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Business Development

From identifying key partners to establishing sustainable sales channels, we help clients grow their presence and build long-term value in the Vietnamese market.

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Employer of Record

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Market Entry

We guide animal pharma manufacturers through every step of launching in Vietnam, from regulatory approvals to distribution setup, ensuring a smooth, timely, and compliant market introduction.

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Market Intelligence

Our research-driven insights uncover market trends, customer behavior, and competitive landscapes, enabling informed decisions for successful expansion strategies.

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Operational Support

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Product Registrations

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Regulatory and Compliance

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Regulatory Compliance

We navigate Vietnam’s complex veterinary and agricultural regulations, preparing accurate dossiers and securing permits to meet both national and provincial requirements.

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TRC

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Work Permits

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FAQ

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We combine deep expertise in Vietnam’s veterinary pharmaceutical landscape with a hands-on approach to market entry. Our team understands both international quality standards and local regulations, ensuring your products are launched smoothly and compliantly.

Vietnam’s fast-growing livestock, aquaculture, and animal health markets offer expanding opportunities for global suppliers. Rising demand for quality veterinary medicines, vaccines, and feed additives makes it an ideal destination for American and European manufacturers.

Vietnam’s regulations for animal pharmaceuticals are comprehensive and strictly enforced. We guide you through each step, from dossier preparation and product registration to import permits and labeling compliance, minimizing delays and costly errors.

We deliver a full spectrum of services including market entry consulting, market intelligence, regulatory compliance, and business development. Our local network spans regulatory authorities, distributors, and industry partners across all major regions in Vietnam.

We work as your in-country extension, managing critical processes from regulatory submissions to market research and partner negotiations. Our approach is transparent, responsive, and focused on delivering measurable results for your expansion into Vietnam.

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