logo

Start a Pharmaceutical Company in Singapore: Steps & License Requirements

In this comprehensive guide, we will explore the steps to start a pharmaceutical company in Singapore. Further, we will be explaining the documents required, benefits, and licensing requirements for starting a pharmaceutical company in Singapore.

GET EXPERT
ASSISTANCE

    Note:This form is not for job seekers

    or salary employees.

    Table of Contents

    The choice to launch a pharmaceutical company is a calculated move that needs thorough preparation and analysis of the industry.

    Singapore, with its pro-business policies, strong regulatory framework, and advantageous location, stands out as an attractive destination for entrepreneurs and investors looking to establish a pharmaceutical company. In this comprehensive guide, we will explore the ins and outs of starting a pharmaceutical company in Singapore, emphasizing the steps, documents required, benefits, and licensing requirements. Our goal is to provide a clear roadmap for opening a pharmaceutical company in Singapore, making the process more accessible and appealing to foreign business entrepreneurs and investors.

    Why Set Up a Pharmaceutical Business in Singapore?

    Strategic Location and Robust Infrastructure

    Singapore is a gateway to the enormous Asian market because of its ideal location in the center of Asia. Its world-class infrastructure, including state-of-the-art research facilities and a strong logistics network, provides an ideal base for establishing a pharmaceutical company in Singapore.

    Supportive Government Policies

    The Singaporean government is known for its pro-business stance, offering various incentives and support programs for the pharmaceutical sector. This makes starting a pharmaceutical company in Singapore not just feasible but also highly beneficial.

    Skilled Workforce

    Access to a highly skilled and educated workforce is another compelling reason to consider opening a pharmaceutical company in Singapore. The talent pool here is well-versed in the latest developments in industry and technology.

    Steps to Start a Pharmaceutical Company in Singapore

    1. Research and Planning

    Prior to beginning the procedure of starting a pharmaceutical company in Singapore, thorough research and planning are essential. Recognize the competitive environment, market demand, and regulatory environment. This step is crucial for creating a solid business plan that will direct the expansion of your enterprise.

    2. Choose a Business Structure

    Choosing the appropriate business structure affects both the legal and financial elements of your organization. In Singapore, entrepreneurs commonly choose between a private limited company and a subsidiary of a foreign corporation. Each structure has its advantages, and speaking with an expert from OnDemand International can help you make an informed decision.

    3. Register Your Company

    Registering your pharmaceutical company with the Accounting and Corporate Regulatory Authority (ACRA) is a necessary step. Ensure that you have a unique company name and a registered office address, and fulfill all the requirements outlined by ACRA.

    4. Obtain Necessary Licenses

    In order to guarantee both public health and product safety, the pharmaceutical sector is heavily regulated. Obtain the required licenses from the Health Sciences Authority (HSA) in Singapore. This step entails providing thorough details about your goods, production procedures, and quality assurance standards.

    5. Secure Funding

    A substantial financial commitment is needed to launch and expand a pharmaceutical business. Examine your possibilities for finance, including grants from the government, venture capital, and financial institutions. Singapore supports expanding the pharmaceutical industry by providing a range of subsidies and incentives.

    6. Set Up Manufacturing and Distribution Channels

    Establishing manufacturing facilities and distribution channels are crucial components of your pharmaceutical business. Ensure compliance with Good Manufacturing Practice (GMP) standards and develop a reliable distribution network to reach your target markets efficiently.

    7. Hire Qualified Personnel

    Assemble a team of experienced professionals with expertise in pharmaceutical research, development, and regulatory affairs. Having a skilled and knowledgeable team is essential for navigating the complexities of the industry and ensuring compliance with regulatory standards.

    Documentation needed to start a Pharmaceutical Company in Singapore

    Detailed Business Registration Documents

    • Company Name Approval: Secure a unique and relevant name for your business, which can be reserved through ACRA’s online portal.
    • Detailed Business Activity Description: Outline the specific pharmaceutical activities your company will engage in, including research, manufacturing, or sales.
    • Shareholder and Director Information: Provide details of all shareholders and directors, including their identification and background information.
    • Registered Business Address Proof: Provide documentation of your company’s local registered address. This might be a manufacturing plant or a commercial office.
    • Company Secretary Appointment: As required by Singaporean corporate law, hire a competent company secretary within six months of establishment.

    Additional Documents for Operational Set-Up

    • Lease Agreements: If renting a facility, provide lease agreements to prove the legitimacy of your operational base.
    • Proof of Compliance with Safety Standards: Documents demonstrating that your facility meets Singapore’s safety and environmental standards.
    • Employment Contracts: For hiring staff, have legally binding employment contracts that adhere to Singapore’s labor laws.

    License Requirements for Pharmaceutical Companies in Singapore

    The pharmaceutical industry is highly regulated to ensure the safety and efficacy of medical products. In Singapore, pharmaceutical companies must comply with the following license requirements:

    1. Importer’s License

    If your business involves importing pharmaceutical products into Singapore, obtaining an Importer’s License is mandatory. This license ensures that the imported pharmaceuticals meet Singapore’s strict quality and safety regulations. Applicants must demonstrate adequate storage facilities and a robust tracking system for the products they import.

    2. Wholesale Dealer’s License

    Companies engaged in the import, production, or distribution of pharmaceutical products in Singapore must possess this license. The Health Sciences Authority (HSA) issues Wholesale Dealer’s Licenses to ensure that companies meet the necessary quality and safety standards.

    3. Good Manufacturing Practice (GMP) Certification

    Companies engaged in the manufacturing of pharmaceutical products must adhere to Good Manufacturing Practice (GMP) standards. Obtaining GMP certification from the HSA is crucial in order to ensure the safety and quality of medicinal goods.

    4. Product Registration

    Before marketing and selling pharmaceutical products in Singapore, companies must register their products with the HSA. During this process, comprehensive data regarding the product’s ingredients, production method, and quality assurance procedures must be submitted.

    Conclusion

    Starting a pharmaceutical company in Singapore offers a blend of opportunities and challenges. With its strategic location, supportive government policies, and robust regulatory environment, Singapore stands out as a top destination for pharmaceutical ventures. Ensuring compliance with regulatory requirements, securing the necessary licenses, and leveraging the available benefits are key to the successful establishment of your pharmaceutical company in Singapore.