All industries in Thailand, including cosmetics, food, medical devices, and nutrition, develop very fast, which further increases the complexity of the set regulations, thus making the expert regulatory support a matter of higher importance. With an experienced regulatory consultant in Thailand, one can ensure a smooth process of product registration along with compliance with the Thai Food and Drug Administration requirements.
In this article, we walk you through what a regulatory consultant does, why engaging one may be essential for your business, and how to select the right regulatory partner for your company.
Role of Regulatory Consultant in Thailand
A regulatory consultant must comply with the Thai FDA regulatory framework. They must support with the licensing and product registration. The primary responsibilities in product registration include dossier review, compilation, and submission, as well as acting as the Marketing Authorization Holder (MAH). The consultant must have knowledge of the labelling requirements as per Thai FDA regulations. The consultant must be able to handle the post marketing surveillance, renewals and variations. Wherever applicable, the consultant must also provide pharmacovigilance and quality support.
Qualifications of Regulatory Consultants in Thailand
- A degree in pharmacy or life sciences or equivalent field at the bachelor’s or master’s level is mandatory.
- Experience in regulatory affairs, familiarity with new submissions, post approval, maintenance, etc. is required.
- Must be well-versed in the regulatory framework of the Thai FDA.
- Should be conversant with electronic submission platforms.
- Must be aware of the requirements for pharmacovigilance.
- Should exhibit excellent interpersonal and communication abilities.
- Must be proactive and detail oriented.
When Should Companies Engage a Regulatory Consultant in Thailand?
Hiring a regulatory consultant is useful for establishing a local presence and when one is not familiar with the local regulations and language requirements. Also, when there is a need for local MAH or representative.
Major Steps in Hiring Regulatory Consultant in Thailand
A brief understanding to consultant should be provided regarding the product category like if the product is pharmaceutical, medical device, cosmetic, food supplement etc. Type of the support required if it is registration, submission, audits etc. When the objectives are clear it is easier to evaluate the correct expertise.
The consultant must have proven experience in the specific product category. Must have successful Thai FDA projects.
The consultant should have local regulations knowledge and know to operate the submission portals.
The company should evaluate the local presence of the consultant in Thailand like a registered office or local entity in Thailand. The consultant must act as Market Authorization Holder (MAH) and must have grip over administrative procedures.
The company must ask for the pricing models of the consultant like the hourly rates, fixed packages for registration and labelling works etc.
Questions to Ask Before Hiring Regulatory Consultant
The following crucial factors should be carefully considered when choosing a regulatory consultant:
- Qualifications
- Prior local experience
- In depth knowledge about Thailand’s regulatory pathway and strategy
- Previous experience and interactions with ThaiFDA
- Dossier preparation and some steps
- Clear communication skills
- Realistic timelines and transparent costing structures
Cost Considerations and Commercial Models
While appointing a regulatory consultant in Thailand, the company must consider the costing approach like if it is a monthly or time and material basis or if there is a fixed cost for a particular activity. The consultant must provide transparent cost breakdown and the respective milestones. Additionally, the consultant’s costing must be solely based on scope of work, product type, class and number and complexity of the regulatory pathway.
Hiring Mistakes Made by Companies While Hiring the Regulatory Consultant
Mistakes that companies make while hiring a regulatory consultant include selecting a candidate based on a lower price. Hiring a candidate without much technical understanding and by not verifying their experiences.
Hiring a regulatory consultant in Thailand is like an investment for compliance, market entry, speed and success. With the right candidate, you can navigate through the local requirements very confidently, and your product entry into the Thai market becomes easier.
How Artixio Regulatory Consultants Support Market Entry in Thailand
Artixio’s regulatory consultants bring strong academic qualifications and over 10–15+ years of hands-on regulatory experience. The team begins with product classification and defining the regulatory pathway as per ThaiFDA requirements. This is followed by a comprehensive regulatory gap analysis, evaluation of the acceptability of foreign approvals and clinical or performance data and support in pre-submission discussions with TFDA, and developing realistic timelines and approval forecasts.
Regulatory experts at Artixio ensure that the packaging and labelling completely adhere to ThaiFDA regulations while preparing, reviewing, and compiling the technical dossiers. The consultants oversee application submission and serve as the Health Authority’s primary point of contact.
Artixio’s RA Experts in Thailand manage the deficiency letters, requests and meetings. After approval consultants support variations, renewals and will do lifecycle management and will perform all the post marketing surveillance activities.
Through this comprehensive approach, the consultants deliver full regulatory support and strategic planning to enable a smooth and successful market entry in Thailand. Contact us today at info@artixio.com.
FAQs
What is the difference between Marketing authorization holder (MAH) and regulatory consultant?
The MAH acts as the legal entity for all the pharmaceutical products’ safety, quality and regulatory compliance. MAH has the legal authorization to market. A regulatory consultant, on the other hand, is a professional who can advise and provide support to the MAH for all submission and other requirements.
Can one consultant manage multiple product categories?
Some consultants can. However, it is important to confirm the category expertise of the consultants.
Does ASEAN Common technical dossier play a role in Thailand?
Yes, because Thailand is an ASEAN member, the dossier has to be prepared according to ASEAN Common technical dossier (ACTD) format and the main aim for this is that all the ASEAN countries will have harmonize regulatory requirements.