Guide to Selecting Regulatory Affairs Staff and Consultants
When developing products like medical devices and pharmaceuticals, navigating regulatory affairs is unavoidable. On the other hand, simply outsourcing everything can lead to enormous costs.
What to Know Before You Hire
Hiring a regulatory affairs expert or consultant just because you're unfamiliar with the field might be a bit premature. It's best to carefully consider if it's truly necessary before making a move.
First, you need to ask yourself whether a startup should handle its own regulatory approval applications at all. For pharmaceutical startups, it's common to handle development up to a certain point and then license the product out to a major pharmaceutical company, eliminating the need for an in-house regulatory team. Similarly, many medical device startups lack the resources and network for the entire process, so they often entrust the regulatory application and sales to a company that already holds a marketing authorization license and has established sales channels.
During the business planning stage, you should decide how much of the process your company will handle and plan your regulatory resources accordingly.
Next, let's assume your company does need to handle regulatory tasks internally.
In reality, it's quite common for someone with no prior experience to take on the regulatory role at a startup. There are a few reasons why this is possible.
One reason is that, to gain regulatory approval, you must reach a prior agreement with the PMDA (Pharmaceuticals and Medical Devices Agency) for anything you do. No matter what advice a regulatory consultant gives, the final decision-maker is the regulatory authority (PMDA). This means that even if you hire regulatory staff or a consultant, they will ultimately need to consult with the PMDA anyway.
Another reason, as mentioned in other content, is that public institutions now offer free information, advice, and even hands-on support. At MEDISO, for example, they can attend PMDA meetings with you from a neutral standpoint if you wish, and they can help you reconfirm what was discussed in follow-up meetings. Therefore, a startup's basic stance should be to get information and advice for free from public bodies and pay consultants for the actual hands-on work.
Furthermore, the PMDA offers "RS Consultations," which are specifically designed for academia and startups with limited regulatory experience. In the initial comprehensive RS Consultation, they will even advise you on how to proceed with future consultations.
Given all this, hiring an experienced regulatory person or consultant to handle the practical tasks offers the best cost and time performance only when your company truly lacks the internal resources to manage anything on its own.
First, Clarify Your Company's Needs
The first step is to objectively assess your company's situation and specify what you cannot do internally. Let's break down your current situation and challenges from the following perspectives.
Understand the Types of Support
Once you have a clear understanding of your needs, the next step is to understand the various support models offered by regulatory consultants and find the type that fits you best.
Compare and Consider Outsourcing Options
Once you understand your needs and the type of consulting you're looking for, it's time to consider specific partners. Each has its own characteristics, so compare them carefully.
Points to Keep in Mind
When selecting a partner, pay close attention to the experience of the individual who will be in charge. Many consultants previously worked in regulatory departments at pharmaceutical companies, but tasks in those departments are often siloed, so few have experience with the entire process.
Furthermore, regulations for pharmaceuticals and medical devices are quite different, and it's rare to find someone who has handled both regulatory affairs and insurance reimbursement.
For these reasons, a firm generally offers more versatility than an individual and may be able to switch your consultant if the initial one isn't a good fit. Be sure to thoroughly verify their experience in the specific tasks you need help with.
Recommendations for Startups
The most cost-effective approach is to handle as much as you can with your existing staff.
Try to make full use of AI. Depending on how you use it, it can provide surprisingly specific and accurate guidance on how to proceed. If you're not sure how to use it, feel free to contact our office.
If you still find that you need help, the basic principle should be to hire people only when absolutely necessary, and preferably on a service consignment contract basis. The reality in Japan is that it is difficult to dismiss permanent employees.
If things still aren't running smoothly after that, then it may be a good idea to bring in an external regulatory consultant.
In any case, the most important thing is to clearly identify which parts of the process your company cannot handle internally. Doing so will naturally make it easier to choose the right path forward.
@K.Kamitani
What to Know Before You Hire
Hiring a regulatory affairs expert or consultant just because you're unfamiliar with the field might be a bit premature. It's best to carefully consider if it's truly necessary before making a move.
First, you need to ask yourself whether a startup should handle its own regulatory approval applications at all. For pharmaceutical startups, it's common to handle development up to a certain point and then license the product out to a major pharmaceutical company, eliminating the need for an in-house regulatory team. Similarly, many medical device startups lack the resources and network for the entire process, so they often entrust the regulatory application and sales to a company that already holds a marketing authorization license and has established sales channels.
During the business planning stage, you should decide how much of the process your company will handle and plan your regulatory resources accordingly.
Next, let's assume your company does need to handle regulatory tasks internally.
In reality, it's quite common for someone with no prior experience to take on the regulatory role at a startup. There are a few reasons why this is possible.
One reason is that, to gain regulatory approval, you must reach a prior agreement with the PMDA (Pharmaceuticals and Medical Devices Agency) for anything you do. No matter what advice a regulatory consultant gives, the final decision-maker is the regulatory authority (PMDA). This means that even if you hire regulatory staff or a consultant, they will ultimately need to consult with the PMDA anyway.
Another reason, as mentioned in other content, is that public institutions now offer free information, advice, and even hands-on support. At MEDISO, for example, they can attend PMDA meetings with you from a neutral standpoint if you wish, and they can help you reconfirm what was discussed in follow-up meetings. Therefore, a startup's basic stance should be to get information and advice for free from public bodies and pay consultants for the actual hands-on work.
Furthermore, the PMDA offers "RS Consultations," which are specifically designed for academia and startups with limited regulatory experience. In the initial comprehensive RS Consultation, they will even advise you on how to proceed with future consultations.
Given all this, hiring an experienced regulatory person or consultant to handle the practical tasks offers the best cost and time performance only when your company truly lacks the internal resources to manage anything on its own.
First, Clarify Your Company's Needs
The first step is to objectively assess your company's situation and specify what you cannot do internally. Let's break down your current situation and challenges from the following perspectives.
- What is your business phase?
- Clarify whether your product development is at the idea stage, basic research, initial design, non-clinical trials, or clinical trial preparation. The required tasks will vary greatly depending on the phase.
- What specific expertise are you lacking?
- Identify the specific knowledge gaps you have, whether it's related to your product's characteristics (e.g., software as a medical device, regenerative medicine, biopharmaceuticals), PMDA consultations, clinical trial design, or navigating overseas regulations.
- Are your internal resources sufficient?
- Check your internal structure. Do you have a dedicated person for regulatory applications? If not, is there a team member who could handle it with the right information and advice? If resources are insufficient, you will need to hire staff or a regulatory consultant to perform the hands-on work.
- What is your biggest immediate challenge?
- Pinpoint the biggest barrier currently hindering your business progress. This could be anything from "We don't know how to make the first contact with the PMDA" to "Past consultations didn't go well" or "We don't have the resources to prepare application documents." This will help you determine whether you need information and advice or practical, hands-on resources.
- What is your budget and timeline?
- Organize your financial and time constraints, such as the maximum amount you can spend on consulting and the deadlines you need to meet.
- By analyzing these points, you can articulate the requirements for the staff or consultant you plan to hire (e.g., their field of expertise, the scope of support, their role). Creating a clear and well-defined request is the most crucial step in preventing a mismatch.
Understand the Types of Support
Once you have a clear understanding of your needs, the next step is to understand the various support models offered by regulatory consultants and find the type that fits you best.
- Spot Consulting
- This model provides one-off advice on specific issues or questions. It's suitable when you have a regulatory person in-house but need an expert's opinion on a specific, highly advanced topic.
- Advisory Retainer
- This involves ongoing strategic advice and decision-making support through regular meetings. However, the actual work is expected to be done by your company. The fee is typically a fixed monthly rate.
- Hands-on / Project-Based Support
- This model involves the consultant taking on or supporting the creation of specific deliverables, such as PMDA consultation documents, Quality Management System (QMS) development, or marketing approval applications. Fees are set on a per-project basis.
- Strategic Partner
- This offers comprehensive, long-term support across the entire business lifecycle, from the initial development stages through to approval, insurance reimbursement, and post-market activities. The fees are typically high, involving a fixed monthly rate or a success-based fee.
- Staff-Type
- While contract forms can vary, this person works as a member of your company's staff, handling regulatory affairs. Startups often use service consignment contracts (業務委託契約) because they allow for flexible adjustment of the scope of work and duration. These professionals are often hired through recruitment agencies that have a pool of freelance or fractional talent.
- By matching these support models with your company's needs, you can identify the most suitable option. As mentioned earlier, since information and advice can be obtained for free from public institutions, a common pattern for startups is to have an existing employee take on regulatory duties or to hire someone on a service consignment contract. In addition to this, depending on resources and experience, you might then delegate the hands-on work to an external consultant.
Compare and Consider Outsourcing Options
Once you understand your needs and the type of consulting you're looking for, it's time to consider specific partners. Each has its own characteristics, so compare them carefully.
- ARO (Academic Research Organization)
- These are research support organizations, often affiliated with university hospitals. For academia or academia-born startups, they are worth considering as they can be the most cost-effective option.
- CRO (Contract Research Organization)
- While their main business is typically conducting clinical trials, most CROs offer regulatory consulting as a functional service. They possess the most know-how regarding clinical trials, so getting a package deal can be very efficient. So-called global CROs with overseas bases can handle regulatory affairs worldwide.
- Regulatory Consulting Firm
- These are firms that specialize in regulatory affairs. They tend to be more expensive than freelance consultants, but they are a viable option if you have no internal resources at all. A point of caution is that smaller firms may only be able to handle regulations in Japan, requiring you to find separate consultants for each country.
- Regulatory Consultant (Freelancer)
- These are individuals who undertake regulatory work on a freelance basis. They can be more affordable than consulting firms, but quality can be inconsistent, making them a higher-risk option.
Points to Keep in Mind
When selecting a partner, pay close attention to the experience of the individual who will be in charge. Many consultants previously worked in regulatory departments at pharmaceutical companies, but tasks in those departments are often siloed, so few have experience with the entire process.
Furthermore, regulations for pharmaceuticals and medical devices are quite different, and it's rare to find someone who has handled both regulatory affairs and insurance reimbursement.
For these reasons, a firm generally offers more versatility than an individual and may be able to switch your consultant if the initial one isn't a good fit. Be sure to thoroughly verify their experience in the specific tasks you need help with.
Recommendations for Startups
The most cost-effective approach is to handle as much as you can with your existing staff.
Try to make full use of AI. Depending on how you use it, it can provide surprisingly specific and accurate guidance on how to proceed. If you're not sure how to use it, feel free to contact our office.
If you still find that you need help, the basic principle should be to hire people only when absolutely necessary, and preferably on a service consignment contract basis. The reality in Japan is that it is difficult to dismiss permanent employees.
If things still aren't running smoothly after that, then it may be a good idea to bring in an external regulatory consultant.
In any case, the most important thing is to clearly identify which parts of the process your company cannot handle internally. Doing so will naturally make it easier to choose the right path forward.
@K.Kamitani