Regulatory Strategy and Drug Development Consultancy

Since 2010, 3D-PharmXchange has been a trusted partner for academia, biotech, and pharmaceutical companies of all sizes, offering expert consultancy in the drug development process. Our team of highly experienced professionals provides strategic guidance and hands-on support to accelerate drug development programs and ensure that its clients needs are fully taken care of every day.

At 3D-PharmXchange, we recognize that the patient is at the heart of everything we do. Our focus is always on delivering safe, effective, and innovative treatments to those who need them most. We ensure that patient needs drive every stage of development, from early discovery to clinical trials, regulatory submission, and market access.

Our expertise includes:

• Small Molecules

• Biologics (including monoclonal antibodies, ADCs, proteins, and vaccines)

• Advanced Therapy Medicinal Products (ATMPs), such as gene therapy & cell therapy

• Combination Products (drug-device combinations)

We work collaboratively with our clients to accelerate their drug development programs by identifying critical gaps in data, selecting the most suitable CDMO and CRO, designing robust and smart clinical protocols, ensuring regulatory compliance. From guiding you through scientific advice with regulatory authorities, to managing the full spectrum of development activities, we offer tailored solutions to bring your compound faster from the lab to the clinic.

Our services include:

• Regulatory Affairs – Regulatory strategy and support with Scientific Advice and agency interaction (EMA, FDA, and other agencies)

• CMC – Support with CDMO selection & management, formulation development & clinical Supplies

• Non-Clinical Development – Program design, CRO selection & management for (GLP) toxicology, safety pharmacology, and ADME

• Clinical Development – Protocol design, Clinical pharmacology, biomarker selection, and clinical trial strategy & oversight

• Quality Assurance – Building Quality Management Systems (QMS), QA management support, auditing and QA operations

• Multidisciplinary Project Leadership over development teams

With a growing team of over 30 consultants and a track record of serving more than 300 clients, 3D-PharmXchange has become a trusted partner in the global life sciences community. Our mission is to help bring your next breakthrough treatment to market efficiently and effectively, while ensuring the highest quality in every step of the development journey.