The Dutch drug development company that partners up with you and provides expertise that ranges from small molecules and re-purposed drug products to ATMPs and oligonucleotides. We help you in asking the right questions once you identify a lead candidate, lead your development programs toward approval, and provide you with the regulatory support to ensure your product stays on the market.
The Solutions We Deliver
Non-Clinical expertise to identify and solve potential gaps and give you the competitive advantage you need to get you to the clinic.
Clinical expertise to enable decisions based on evidence and ensure that your trials meet milestones and budget expectations.
CMC expertise that ranges from small molecules to oligos and allows you to work toward an efficient development program and a stable product.
Regulatory Affairs expertise in pre- and post-authorization regulatory activities to increase the chances of approval and continued compliance.
Navigating Development
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 have experience in the pharmaceutical and biotech industry and combine their strategic experience with a hands-on operational perspective. Besides being specialists in their areas of expertise, our consultants are all skillful project managers and have a habit of meeting deadlines and staying within budget.
Where are you in development?
Click any of the phases to see how 3D-PharmXchange can be of service.
Non-Clinical
Every non-clinical expert in our company has at least 20 years of experience in the pharmaceutical and biotech industry and together we cover a broad range of indications and therapies, ranging from small molecules, vaccines and biotechnology-derived products to novel therapies such as oligonucleotides and advanced therapy medicinal products (ATMPs) including gene therapy, cell therapy and tissue engineering products.
Related Expertises
- Pharmacology (Proof of Concept)
- Toxicology
- Non-clinical development strategy
- Due diligence and gap analysis
- Preparation of regulatory documentation
- CRO selection and contract negotiation
IND / CTA
Our regulatory experts have years of experience with the Health Authorities and are adept at providing you with a customized regulatory strategy and support you with the first steps of any drug’s development process.
Related Expertises
- Development of regulatory strategies
- Prepare Target Product Profile
- Scientific Advice
- Orphan Drug applications
- Paediatric Investigation Plans
- IND/CTA writing, compilation and submissions
Phase I
Our multidisciplinary teams collaborate closely with you to develop tailored clinical strategies for your study and aim to maximize efficiency and mitigate risk. Our approach minimizes the time spent on reaching critical decisions early on by asking the right questions and focusing on innovative trial design.
Related Expertises
- Formulation Development
- Clinical Trial Design
- Pharmacokinetics
- Biomarker Development
Phase II
If your product is determined to be safe in a Phase I clinical trial, 3D-PharmXchange can assist you with your subsequent Phase II clinical trial. The design of these studies aims to assess drug efficacy and safety and requires more considerable group sizes.
Related Expertises
- Clinical Pharmacology
- Pharmacokinetics & Pharmacodynamics
- Biomarkers & Efficacy Endpoints
- Orphan Drug Designation
- Clinical Trial Materials
PHASE III
These utter size of modern phase III trials also mean increasingly complex study designs, challenges in patient enrollment, and demand for specific therapeutic expertise. Our consultants apply a risk-based, data-driven approach in their clinical trial strategies to ensure the feasibility of your studies. By taking into account risk mitigation and contingency plans, we ensure that trials meet your milestones and budget expectations.
Related expertise
- Design Pivotal Trials
- Commercial Formulation
- KOL Meetings
- Safety & Efficacy Biomarkers
Registration
The complexity of drug development and the registration process requires a combination of regulatory intelligence and scientific know-how. Our experts offer both. We can support you from the final stage of development to submission of the dossier.
Related Expertises
- Late stage FDA/EMA meetings
- Develop NDA/MAA submission strategy
- Authoring and reviewing eCTD documents
- Regulatory Submission Project Management
- Managing Agency Response process
Post-Marketing
We take on lifecycle management (maintenance) activities on a case-by-case basis and in cases of peak workload we can provide you with tactical, hands-on support. The flexibility of our organization ensures tailored solutions that address your needs above all.
Related Expertises
- Variations
- Renewals
- Line-extensions
- Risk Minimization Materials
- Portfolio Management
News & Content
At 3D-PharmXchange, we believe knowledge needs to be shared to develop clinical programs and to meet unmet patient needs. This is why we share publications, blogs, and other insights regularly. Feel free to leave us a message if you’d like more information on a specific topic.
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A Decade Of Drug Development
"We can help companies better by being a smart, independent specialist in the service of drug development", that was, after solid careers at various Pharma companies concluded by Ronald van der Geest, Inez de Greef, and then Lars Bastiaanse, withdrew ten years ago....
