Thailand’s regulated health-product sectors, which include cosmetics, food, medical devices, medicines, and herbal products, are subject to specific regulatory requirements. This makes expert regulatory support quite important for businesses that want market entry or to maintain compliance. 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 should understand the Thai FDA regulatory framework properly and be up to date. They must support clients with licensing, product registration, or notification requirements–whatever applies to specific products. Their primary responsibilities may include dossier review, compilation, submission support, and regulatory communication.
Where it applies, the consultant may also support the company in setting or managing the responsibilities that a local applicant or Marketing Authorization Holder (MAH) has to undertake. The consultant should know Thai FDA labeling regulations. They should be able to handle after marketing surveillance, renewals, and variations. They should also be able to provide or coordinate pharmacovigilance and quality-related support.
Qualifications of Regulatory Consultants in Thailand
Regulatory consultants in Thailand should preferably have the following qualifications to become valuable to companies:
- A degree in pharmacy, life sciences, or a related field can be valuable. Especially when the consultant is supporting technically complex regulated products
- Experience in regulatory affairs, familiarity with new submissions, post-approval, maintenance, etc., is an important selection criterion.
- Should be well-versed in the regulatory framework of the Thai FDA.
- Should be conversant with electronic submission platforms.
- The consultant should understand the pharmacovigilance requirements where medicines or other products are concerned. Also, where there are safety-reporting obligations.
- Should have excellent interpersonal and communication abilities
- Should be proactive and detail-oriented
When Should Companies Engage a Regulatory Consultant in Thailand?
Hiring a regulatory consultant can be useful when the following happens:
- A company is not familiar with Thailand’s regulatory requirements, submission procedures, or local business practices
- To confirm the legal requirements that apply
- A local applicant, importer, Marketing Authorization Holder (MAH), or authorized representative is needed
Major Considerations in Hiring a Regulatory Consultant in Thailand
Some things you should consider when hiring a regulatory consultant in Thailand are as follows:
Know their Expertise & Clarify your Objectives
You should choose a consultant according to their expertise in a specific product category. For example, a consultant qualified in pharmaceuticals, medical devices, cosmetics, food supplements, etc., would be needed if your product is any of these. The type of support required may also be different for registration, submission, audits, etc. Your objectives should be clear before you evaluate the correct expertise.
Check Proven Experience
The consultant should have proven experience in the specific product category. Where possible, they should show a demonstrable track record of relevant Thai FDA projects. They should have knowledge of local regulations and know how to operate the submission portals.
Look for their Local Presence
The company should evaluate whether the consultant has an established local presence. Or, it works with an appropriate Thai entity where this is relevant to the regulatory pathway. If the product requires a local applicant, importer, MAH, or authorized representative, the company should clearly provide who will hold that legal responsibility.
Consider their Pricing Models
The company should ask for the pricing models of the consultant. It includes the hourly rates, fixed packages for registration and labelling work, etc. Look for their costing approach, like if it is a monthly or time- and material-based approach, or if there is a fixed cost for a particular activity. The consultant should provide you with a transparent cost breakdown and the respective milestones. The consultant’s costing should be based solely on the scope of work, product type, class, number, and complexity of the regulatory pathway
Questions to Ask Before Hiring a Regulatory Consultant
Here are a few questions you can ask a regulatory consultant to be sure of their work:
- Have you handled regulatory submissions for products in our specific category in Thailand?
- Do you have experience or examples of similar Thai FDA projects you have handled before? How did they go? Were they successful or not?
- What regulatory pathway would apply to our product? What are the crucial requirements we should prepare for?
- Who will handle the preparations, review, and submission of our dossier?
- Will you communicate directly with the Thai FDA on our behalf? How will you contribute during regulatory queries or deficiencies?
- Does our product require a local applicant, importer, Marketing Authorization Holder (MAH), or authorized representative? Who will be taking that responsibility?
- What documents, testing, clinical evidence, or other supporting data would be needed in the case?
- How will you assess our existing dossier and find gaps before submission?
- What are the expected regulatory timelines? Which factors could cause delays?
- What is included in your fee? Which government fees, testing costs, translations, or other expenses are charged separately? Are there hidden charges?
- What post-approval support do you provide if we ask for renewals, variations, lifecycle management, and applicable pharmacovigilance activities?
- Who will be our day-to-day point of contact? How will we receive updates on the application?
Hiring Mistakes Made by Companies While Hiring the Regulatory Consultant
Mistakes that companies make while hiring a regulatory consultant include selecting a candidate based primarily on the lowest price. Hiring a candidate without much technical understanding and not verifying their experience also invites problems later.
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 Thai FDA requirements. This is followed by a comprehensive regulatory gap analysis, evaluation of the acceptability of foreign approvals and clinical or performance data, support in pre-submission discussions with them, and developing realistic timelines and approval forecasts.
Regulatory experts at Artixio ensure that the packaging and labelling completely adhere to Thai FDA 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 and renewals. They will do lifecycle management and will perform all 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 a Marketing Authorization Holder (MAH) and a regulatory consultant?
The MAH acts as the legal entity for relevant 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 submissions and other requirements.
Can one consultant manage multiple product categories?
Some consultants can. However, confirming the category expertise of the consultant team is important
Does the ASEAN Common Technical Dossier mean anything in Thailand?
Yes. The ASEAN Common Technical Dossier (ACTD) is important for pharmaceutical registration in Thailand. The Thai FDA states that pharmaceutical registration documents can be prepared according to the ASEAN Common Technical Dossier (ACTD) or the ICH Common Technical Document (ICH CTD). It depends on the applicable pathway. ACTD is specifically intended for pharmaceutical registration applications in ASEAN.
What are some factors to consider before hiring a regulatory consultant in Thailand?
The following crucial factors should be carefully considered when choosing a regulatory consultant:
- Qualifications
- Prior local experience
- In-depth knowledge of 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
