Strategic Regulatory Partner for Success in Singapore

  • Tailored Regulatory Support
  • Product Maintenance & Compliance
  • Flexible Regulatory Teams

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Greetings from
Freyr Singapore

Due to its central location in Asia, Singapore offers potential growth opportunities for Medical Devices, Pharmaceuticals, Cosmetics and Food Supplements manufacturers across the globe. The Health Sciences Authority (HSA) under the purview of Ministry of Health (MOH) regulates all the procedures. Though the Regulatory system in the region believed to be industry-friendly, it’s constantly evolving regulatory frameworks and registration & licensing procedures might pose a great challenge for manufacturers to keep pace with the standards.

Freyr, as a global Regulatory partner can assist you prepare necessary Regulatory documents and submit your applications to the Singaporean regulatory authorities. Freyr’s regulatory affairs (RA) experts will navigate you through the regulatory system of Singapore to obtain product registrations and approvals in short timeframes and the most cost-effective way possible. Freyr’s Regulatory Affairs services for Singapore span across:

Industries We Serve in Singapore

With an advanced healthcare system, Singapore is regarded as a key drug market by renowned global pharmaceutical companies. Medicinal products in Singapore are regulated by the Health Science Authority (HSA) under Health Products Act 2007, and they must obtain necessary approvals to be distributed and marketed in the country. For innovator products, a New Drug Application (NDA) should be filed and for generic drugs, it should be a Generic Drug Application (GDA) application. All applications to the HSA must be filed or submitted through the System for Products And Registrations (SPAR). Right from compiling dossiers as per pre-defined formats, assessing ingredient limits to handling submissions through established systems, new market entrants may find it difficult to navigate the country’s Regulatory procedures.

Medical devices in Singapore are regulated under the Health Products Act (HPA) and its Health Product (Medical Devices) Regulations 2010.

Cosmetics play an important role in enhancing one’s inherent beauty and physical features. People are increasingly using cosmetics in their daily routine, including various types of fragrances and deodorants. This growing demand for cosmetic products has, in turn, led to the growth of the cosmetics market across the world.

In Singapore, food and supplements fall under the purview of the Singapore Food Agency (SFA). The import and sale of these products in Singapore are governed by the Sale of Food Act and the Singapore Food Regulations. Importers must ensure that their products comply with the Singapore Food Regulations and labeling requirements as per the SFA guidelines. Meanwhile, medicinal and other health-related products are regulated under the Health Sciences Authority (HSA) regulations; including Western medicinal products, Chinese proprietary medicines, and cosmetic products.

Handling chemical products to minimize the risk to human beings and the environment is challenging. Many countries, including Singapore, incorporate complex Regulatory processes to adhere right assessments for potential hazards in the chemical products for humans and the environment during production, processing, and distribution. In such scenarios, manufacturers must consider the GHS framework and information on various country-specific approaches for the risk management of chemical products.

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory affairs & Regulatory intelligence
  • Medical writing
  • product classification: food, health supplement, functional food, TCM, OTC/drug
  • NCE/NDA registration dossier compilation
  • Product license maintenance
  • Regulatory CMC strategy
  • Drug Master File (DMF) compilation for open and closed parts
  • Authorized representation
  • Regulatory Intelligence reports.

Freyr Advantages

  • Strategic local health authority contacts - with HSA
  • Proven case of 250 + Submissions
  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines

Our Location in Singapore

BLK 531A Upper Cross Street,
#04-95 Hong Lim Complex
Singapore 051531