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Freyr Expertise

  • End-to-end registration support
  • Authorized local agent support
  • Regulatory affairs consulting
  • Gap analysis of the dossier as per the Thailand FDA Regulatory requirements 
  • Query support management till approval
  • Pharmaceutical product compliance maintenance
  • Ad-hoc Regulatory consultation
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Greetings from Freyr Thailand

Freyr is one of the largest global, Regulatory-focused solutions and services companies. We support Life Sciences companies entering Thai Pharma market in their entire Regulatory value chain, ranging from Regulatory strategy, market intelligence, local representation, and post-approval product maintenance functions. Thai Food and Drug Administration (Thailand FDA) is the Regulatory body responsible for the registration of medicinal products, medical devices, food and food supplements, and cosmetics products.

With our on-ground team of Thai Regulatory experts, we support you in obtaining approvals from the PMDA and ensuring a smooth market entry of your product in Thailand.

 

Industries We Serve

Thailand's pharmaceutical market has grown significantly in the past few years due to impressive developments in the public healthcare system. Thailand presents a significant growth opportunity for multinational pharmaceutical firms looking to expand their presence in the emerging markets of Asia Pacific. The main Regulatory body of the pharmaceutical sector in Thailand is the Thai Food & Drug Administration (FDA), which operates under the auspices of the Ministry of Public Health. The Agency regulates pharmaceutical product registration in Thailand. With updated Regulatory intelligence over the new Regulatory system of Thailand, Freyr assists new market entrants to keep pace with the evolved Regulatory requirements related to registrations, dossier compilation, and submissions for the necessary market authorizations.

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Medicinal Products Regulatory Support in Thailand

Thailand is one of the major medical device markets in Southeast Asia. Medical devices in Thailand are regulated by the Thailand Food and Drug Administration (TFDA) under the Ministry of Public Health (MOPH), while the assessment of the technical data is done by the Medical Device Control Division (MDCD). Freyr, as a leading Regulatory consultant, can assist you through the TFDA product registration and licensing processes and offers expertise in end-to-end Regulatory services in Thailand to secure approval for your medical devices.

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Medical Devices Regulatory Support in Thailand

The Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health (MOPH) is responsible for regulating food and food supplements under the Food Act. The main regulation controlling the food products in Thailand is the Food Act B.E. 2522 (1979), which provides the government and officials with authority to control domestic production, and imports and exports of food products for sale as well as the criteria and penalties for food businesses in the country. Freyr assists manufacturers to encash the growing Thailand food and food supplements market with end-to-end Regulatory services in Thailand.

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Food supplements Regulatory Support in Thailand

An increased consciousness regarding personal appearance among individuals is driving the growth of the global cosmetic industry. In Thailand, the aging population is a growing segment. especially in the skincare and oral care segments. Enhanced interest in natural and organic cosmetics is an important factor that has increased the sale of cosmetic products in Thailand. The Food and Drug Authority (FDA) of Thailand (Thai FDA) has adopted the guidelines of the ASEAN Cosmetic Directive (ACD) and is in line with the Association of Southeast Asian Nations (ASEAN). As a proven partner, Freyr is specialized in cosmetics registration with the Thai FDA. Freyr has extensive experience in providing cosmetics Regulatory services for Thailand.

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Cosmetics Regulatory Support in Thailand

Freyr Digital

Freyr SUBMIT PRO
Freyr SUBMIT PRO, an eCTD Software, Suits All Your Submission Requirements
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Freyr IMPACT
An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
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Freyr Label 360
Freyr Label 360 The Real-time is Now REAL Content To Carton.
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Freyr PRISM
Freyr SPAR is one such RIM Solution that enables Life Science organizations to effectively manage the information right from tracking product registrations to generate statistical reports.
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About Freyr

Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.

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Our Regional Expertise

We are a global firm and we have local expertise across the following countries.

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