Regulatory Affairs

Dutch regulatory experts with a global project management track record. By applying decades of experience, we can anticipate challenges and offer well-suited expertise to your advantage.

Working Towards Approval.

Regulatory Affairs is a critical discipline in any pharmaceutical or biotech company and can either make or break your development program. At 3D-PharmXchange, we offer you our experience in pre- and post-authorization regulatory activities to increase the chances of approval and to ensure efficient lifecycle management.

A refined regulatory strategy will not only identify any regulatory challenges but also create regulatory opportunities. Besides identifying risks and mitigation strategies, we also aim to set realistic milestones and deliverables and a feasible communication plan to interact with the Health Authorities.

Our experts can assist you in all stages of development to secure early engagement with regulatory agencies, align development milestones, and ensure continued regulatory compliance. We guide your drug product through the regulatory landscape and support your efforts towards approval.

Pre-Authorization Activities

Scientific Advice – Asking The Right Questions

The combination of scientific expertise and industry know-how at 3D-PharmXchange enables us to support companies in their scientific advice needs.

In addition to representing you at meetings and hearings at the EMA/FDA, we can support the preparation and technical writing that precedes it. Our consultants can assist with the development of the briefing book package and its submission, prepare and submit responses to questions, and train your staff by conduct rehearsals before Health Authority meetings. Following up on the Scientific Advice, our experts can help you interpret and implement the subsequent response into your development program to continue on the way to approval.

Target Product Profile

A target product profile summarizes the intended features, such as indication and dosage and administration, of the product in development. It serves as a guidance for your development plan and as a tool for both internal and external discussions with, for example, investors and regulatory authorities. Based on many years of experience, our experts can work with you on developing this dynamic document.

Regulatory Intelligence – Planning Your Route To Success.

Our experts’ regulatory intelligence allows you to determine the requirements for the various aspects of drug development and clinical trials. They base their advice on years of experience regarding pitfalls in strategic decision-making, interactions with Health Authorities and the process of gaining local or global market approval. Our regulatory intelligence can give you the edge over the competition.

Strategic Regulatory Advice – Navigating The Regulatory Landscape

Our combined experience allows us to develop a regulatory strategy from early development up to regulatory submission and due diligence to identify gaps in existing or new dossiers.

Determining the best filing strategy and choice of regulatory procedure is pivotal to the success of your drug development. Drafting and coordination of your regulatory strategy plan, sharing advice on regulatory deliverables and timelines, and facilitating Health Authority interactions are all crucial elements that we excel in. We invite you to contact our experts for an initial conversation to discuss which strategy would suit your development.

Orphan Drug Designation – Rare Diseases, Rare Expertise. 

To incentivize the development of Orphan Medicines both the EU and the US have economic and regulatory incentives available that enhances the development of products for these rare indications. However, developing an orphan medicine requires distinct scientific and regulatory expertise.

Our strategic regulatory experts can assist in Orphan designation applications to the FDA/EMA and can also assist in the maintenance of the designations. Making use of our multidisciplinary capabilities, we can support the design of a detailed development plan and your clinical trial program.

Paediatric Investigational Plan (PIP) – Safety For Our Youngest Patients.

To support the authorization of drug products, in most cases a drug development company is required to prepare and submit a Paediatric Investigation Plan (PIP – EMA) or Pediatric Study Plan (PSP – FDA). These plans are intended to support safe use of the drug in children.

To meet your objectives, our consultants can assess the right conditions/ indications that should be studied. Additionally, they can evaluate (partial) waiver or deferral options, interact with agencies in case of Paediatric Scientific Advice, and act on your behalf to coordinate the full procedure and represent you at meetings with the Health Authority.

Our offering also includes the preparation and submission of follow-up activities such as PIP modifications and annual reports.

Prime Eligibility Request – Expedited Access For Unmet Needs.

This initiative by the EMA aims to realize drug development for the unmet needs of patients faster, however, most requests until now have been rejected. Although the exact reasons for out-of-scope rejections are not published, experience tells us that application rejections for eligibility to the PRIME Eligibility Requests often do not meet the criteria for the initial assessment.

Our consultants are familiar with both the challenges and best practices in submitting your PRIME Eligibility Request to the authorities as soon as you finish the relevant stage of development. By providing you with preparation support early on, you can generate the robust data on your drug product’s benefit/risks ratio, required for accelerated assessment by the EMA.

Technical Writing – Regulatory Documentation On Time
Our consultants can work in close collaboration with your own team to author and/or review and regulatory documentation as required throughout the lifecycle of your product(s).  The range of our writing capabilities stretches from preclinical and clinical study protocols in early development to submission for market approval, including:

 

  • Clinical Trial Application 
  • IND / NDA 
  • MAA / BLA / ANDA
  • IMPD & Investigator’s Brochure (IB)
  • Study protocols  
  • All CTD Modules
  • Risk Management Plans (RMP)
  • Environmental Risk Assessment for GMOs
Regulatory Intelligence

Regulatory Intelligence – Planning Your Route To Success.
As regulatory operations become more complex, with an increasing number of new products coming into the market and Health Authority rulings to consider, companies can easily stumble on the path to submission to gain approval for their product(s).

Our regulatory intelligence allows you to determine the requirements for the various aspects of drug development and clinical trials. They base their advice on years of experience regarding compliance procedures, manufacturing requirements, pitfalls in strategic decision-making, and the process of gaining local or global market approval. Our regulatory intelligence can give you the edge over the competition.

Strategic Regulatory Advice
Strategic Regulatory Advice – Navigating The Regulatory Landscape
Our combined experience allows us to develop a regulatory strategy from early development up to product maintenance review and identifying gaps in existing or new dossiers.

Determining the best filing strategy and choice of procedure is pivotal to the success of your drug development. The drafting and coordination of your regulatory product development plan, sharing advice on regulatory deliverables and timelines, and facilitating Health Authority interactions are all crucial elements that we excel in. We invite you to contact our experts for an initial conversation to discuss which strategy would suit your development.

Orphan Drug Designation
Orphan Drug Designation – Rare Diseases, Rare Expertise.
To incentivize the development of Orphan Medicines both the EU and the US have economic and regulatory systems available that stimulate these overlooked therapeutic areas. However, developing an orphan medicine follows alternative pathways (development and regulatory) and requires distinct scientific and regulatory expertise.

Our strategic experts can assist in Orphan designation applications to the FDA/EMA and also the maintenance of the designations. Making use of our multidisciplinary capabilities, we can support the setup of a detailed development plan and your clinical trial designs.

Peadiatric Investigational Plan (PIP)
Peadiatric Investigational Plan (PIP) – Safety For Our Youngest Patients.

 

To support the authorization of drug products for our children you need to study its effects in a paediatric population; a Paediatric Investigation Plan (PIP) or Pediatric Study Plan (PSP) is a development plan intended to exactly this. It goes without saying that this vulnerable population requires a well-executed strategy at every step of the way in its preparation and design.

To meet your objectives, our consultants can assess the right conditions/ indications that should be studied using a systematic and meticulous methodology. Additionally, they can evaluate the consideration of a waiver or deferral options, interact with agencies in case of Paediatric Scientific Advice, and act on your behalf to coordinate the full procedures and represent you at meetings with the Health Authority.

Our offering also includes the preparation and submission of follow-up activities such as PIP modifications and annual reports.

Prime Eligibility Request
Prime Eligibility Request – Expedited Access For Unmet Needs.

 

This initiative by the EMA aims to realize drug development for the unmet needs of patients faster, however, most requests until now have been rejected. Although the exact reasons for out-of-scope rejections are not published, experience tells us that application rejections for eligibility to the PRIME Eligibility Requests often do not meet the criteria for the initial assessment.

Our consultants are familiar with both the challenges and best practices in submitting your PRIME Eligibility Request to the authorities as soon as you finish the relevant stage of development. By providing you with preparation support early on, you can generate the robust data on your drug product’s benefit/risks ratio, required for accelerated assessment by the EMA.

Scientific Advice
Scientific Advice – Realizing Constructive Feedback.

The combination of scientific expertise and industry know-how at 3D-PharmXchange enables us to support companies in their scientific advice needs.

In addition to representing you at meetings and hearings at the EMA/FDA, we can support the preparation and technical writing that precedes it. Our consultants can assist with the development of the briefing book package and its submission, prepare and submit responses to questions, and train your staff by conduct rehearsals before Health Authority meetings. Following up on the Scientific Advice, our experts can help you interpret and implement the subsequent response into your development program to continue on the way to approval.

Post-Authorization Activities

Variations, License Renewals, and Line Extensions – Increasing Efficiency In Maintenance.

Our support in Lifecycle Maintenance includes the processing of Line Extensions and Variations. Ranging from new formulations to a novel indication, 3D-PharmXchange can provide you with the necessary support that allows you to focus on your core business.

We can take on Variations and Line extensions on a case-by-case basis and in cases of peak workload, we can provide tactical, hands-on support to relieve your projects. The flexibility our organization offers ensures tailored solutions that address your needs above all. Additionally, we can assist companies in optimizing their regulatory maintenance processes to reduce future costs.

Product Information (PI) – Ensuring Compliance.

After the approval of your product, our RA consultants can support you in the maintenance of regulatory documents.

Most commonly, maintenance activities include the updating of your Core Data Sheet, edits to your product’s patient information leaflet, the SmPC, and the labeling (artwork). Besides writing, we can also take responsibility for reviewing promotional materials and ensure local compliance regulations.

And if needed, we also have access to a network of partners that allow for the translation of technical documents.

Post-Authorization Commitments – Honoring Your Agreements.

After product launch, there are usually various commitments toward the Health Authorities to guarantee continued safety and efficacy. Although not required by a statute or regulation, if you have committed to such studies or clinical trials as a sponsor has agreed to conduct, you have to fulfill these obligations.

These commitments are related to protocol and report review and annual reports regarding the product’s performance.  Our regulatory consultants can help you prep rate, write, review, and submit any of these outcomes and progress reports.

Variations & Line Extensions – Increasing Efficiency In Maintenance.
Our support in Lifecycle Maintenance includes the processing of Line Extensions and Variations. Ranging from new formulations to a novel indication, 3D-PharmXchange can provide you with the necessary support that allows you to focus on your core business.

We can take on Variations and Line extensions on a case-by-case basis and in cases of peak workload, we can provide tactical, hands-on support to relieve your projects. The flexibility our organization offers ensures tailored solutions that address your needs above all. Additionally, we can assist companies in optimizing their regulatory maintenance processes to reduce future costs.

Product Information (PI) – Ensuring Compliance.
After the approval of your product, our RA consultants can support you in the maintenance of regulatory documents.

Most commonly, maintenance activities include the updating of your Core Data Sheet, edits to your product’s patient information leaflet, the SmPC, and the labeling (artwork). Besides writing, we can also take responsibility for reviewing promotional materials and ensure local compliance regulations.

And if needed, we also have access to a network of partners that allow for the translation of technical documents.

Post-Authorization Commitments – Honoring Your Agreements.
After product launch, there are usually various commitments toward the Health Authorities to guarantee continued safety and efficacy. Although not required by a statute or regulation, if you have committed to such studies or clinical trials as a sponsor has agreed to conduct, you have to fulfill these obligations.

These commitments are related to protocol and report review and annual reports regarding the product’s performance.  Our regulatory consultants can help you prep rate, write, review, and submit any of these outcomes and progress reports.Post-Authorization Commitments – Honoring Your Agreements.

 

After product launch, there are usually various commitments toward the Health Authorities to guarantee continued safety and efficacy. Although not required by a statute or regulation, if you have committed to such studies or clinical trials as a sponsor has agreed to conduct, you have to fulfill these obligations.

These commitments are related to protocol and report review and annual reports regarding the product’s performance.  Our regulatory consultants can help you prep rate, write, review, and submit any of these outcomes and progress reports.

License Renewal – Lorem ipsum is simply
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book.rs and other subject matter experts on the topics, trends and market developments that are relevant to clinical trials and realted areas. Remember that you are always invited to request additional information or suggest a topic you would like to learn about.
Susan Vervoordeldonk

Susan Vervoordeldonk

Susan is leading the RA team and has +20 years of experience with expertise that stretches from global regulatory requirements for the development and registration of new medicinal products as well as maintenance of approved drugs

Interested?

Contact us for enquiries regarding our Regulatory Affairs expertise.

e info@3d-pxc.com
t +31 1 353 482 72

Maidstone 48a, 5026 SK Tilburg,
The Netherlands

Pivot Park, RK Building, room 2326,
Kloosterstraat 9,
5349 AB Oss,
The Netherlands

© 3D-PharmXchange 2020
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Our solutions

Navigating milestones successfully is critical for your drug development program to move forward. Besides a focus on quality, our teams aim to ensure that your plans are executed efficiently, cost-effectively, and are ready to partner with you to develop a program customized to your needs. 

Our senior experts can also take on leadership roles to answer to your development program’s specific requirements. Whether they are Non-Clinical, Clinical, CMC, or Regulatory experts they all have hands-on experience with leading large development teams and toward market approval.

Read more about our Leadership Roles.

Non-Clinical

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CMC

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Clinical

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Regulatory Affairs

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Leadership Roles

Our senior experts are selected based on their ability to answer to your development program’s specific requirements. Whether they are Non-Clinical, Clinical, CMC, or Regulatory experts they all have hands-on experience with leading large development teams and toward market approval.

Without exception, we are concerned with the seniority and experience of our candidates required to lead multi-disciplinary teams and to provide you with a balanced expert collaboration that matches your needs.

About us

A company where small dedicated teams and a high level of ownership are the key to success. That is why we treat our clients’ project as if they are our own. From a genuine interest we maintain a close relationship with our clients, in which we value open and honest communication, in order to provide high quality tailored solutions.

Main Office
Maidstone 48a
5026 SK Tilburg
The Netherlands

Satellite Office
Pivot Park RK Building Room 2326
Kloosterstraat 9
5349 AB Oss
The Netherlands

Careers at 3D

No drug is developed by a single person. We understand that it takes teamwork, perseverance to realize something this big. The 3D team works hard with room to laugh and is looking to expand.

At 3D, we believe knowledge needs to be shared to further develop clinical programs, increase market access, and to meet unmet patient needs. This is why we share publications, blogs, and other insights here. Feel free to leave us a message if you’d like more information on a certain topic.