A Decade Of Drug Development

Find out how 3D-PharmXchange has been contributing to the pharma and biotech industry over the past 10 years.

Minipig In Non-Clinical?

Find out how 3D-PharmXchange is delivering success with minipigs in Non-Clinical development.

Antisense Oligonucleotides

Discover how a strategic CMC development plan can save costs in long run.

Navigating Drug Development

3D PharmXchange is the Dutch drug development company that partners with you to provide 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.

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 your drug development process? Click the phases below 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

Our Solutions

CMC expertise that ranges from small molecules to oligos and allows you to work toward an efficient development program and a stable product.

CMC

Non-Clinical expertise to identify and solve potential gaps and give you the competitive advantage you need to get you to the clinic.

Non-Clinical

Clinical expertise to enable decisions based on evidence and ensure that your trials meet milestones and budget expectations.

Clinical

Regulatory Affairs expertise in pre- and post-authorization regulatory activities to increase the chances of approval and continued compliance.

Regulatory