CLINICAL PHARMACOLOGY CONSULT COMPANY

Offering Professional Assistance for Your Drug Development Needs

CLINICAL PHARMACOLOGY CONSULT COMPANY

Offering Professional Assistance for Your Drug Development Needs

Welcome to XP Pharma Consulting

XP Pharma Consulting is a service provider that specializes in the design and implementation of clinical pharmacology-guided drug development strategies across various therapeutic areas, from early to late development and through registration.

XP Pharma Consulting uses pharmacokinetics (PK), pharmacodynamics (PD), and PK/PD modeling and simulation techniques to advance the understanding of drug properties, enhancing informed decision-making by the client at each stage of drug development.

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Welcome to XP Pharma Consulting

XP Pharma Consulting is a service provider that specializes in the design and implementation of clinical pharmacology-guided drug development strategies across various therapeutic areas, from early to late development and through registration.

XP Pharma Consulting uses pharmacokinetics (PK), pharmacodynamics (PD), and PK/PD modeling and simulation techniques to advance the understanding of drug properties, enhancing informed decision-making by the client at each stage of drug development.

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How Can We Help?

Our goal is to assist you to make better strategic decisions for your drug development. With a clearer understanding of the different drug properties and therapeutic areas, our specialized expertise in clinical pharmacology and PK/PD helps you avoid costly missteps and the possibility of regulatory rejection.

1-development process

Pre-IND to IND: We can help to extrapolate PK and PD data from animals to predict qualitatively the likely behavior in humans. The quantitative framework improve the chance of selecting not only most promising compounds but also correct range of safe doses to first test in humans. Check Our Itemized Services.
Early Phase & Late Phase: Phase 1, 2, and 3 of human assessment generally correspond the first administration to humans, early evaluation in selected patients, and in larger trials, respectively. We can help you to gather PK and PD data at each phase of drug development to effectively define safe and efficacious dosage regimens for optimal individual use. Check Our Itemized Services.
Clinical Pharmacology Studies: Clinical Pharmacology studies are dedicated studies for understanding the PK and PD properties of your drug. We help you to identify needed studies and how to design study and collect data. Check Our Itemized Services.
NDA/BLA Filing: XP Pharma Consulting works with you to prepare NDA/BLA submissions and ancillary materials and documentation. Check Our Itemized Services.

Do you need help with your latest drug development project? Reach out to a friendly and knowledgeable clinical pharmacology consult company, XP Pharma Consulting. We are happy to answer your questions and provide guidance, so call today or fill out the Contact Form to request a proposal.

Why Partner with XP Pharma Consulting?

XP Pharma Consulting supported multiple pharmaceutical companies. Our experiences and competency have been recognized by Record of Success, Publications, and Case Studies. You may check Testimonials provided by our clients.

XP Pharma provides you with quality services. Our consultants have more than two decades of experience and hold advanced degrees in their respective fields.

We are your trusted partner to help guide and support you during your drug development process. No matter what stage of the process is slowing you down, you can count on XP Pharma Consulting for accurate and dependable strategies.

Let XP Pharma Consulting be your go-to clinical pharmacology consulting company. Contact us today to learn more about our experiences and what we can do for you.

 

Testimonials

Clinical Pharmacology Strategy and Writing: “I enjoy working with XP Pharma Consulting. They can manage all aspects of clinical pharmacology projects. For example, XP Pharma supported us in the assessment of drug-drug interactions, integrated non-clinical and clinical evaluation of QT prolongation potential, application for a thorough QT study waiver, design of clinical pharmacology studies, interpretation of population PK and PK/PD modeling results, and scientific writing for regulatory documents”.

Senior Director-Clinical Pharmacology, Pharma Client

Population PK/PD Modeling &Simulation: “XP Pharma has played a significant role in supporting the early clinical development programs of two of our novel molecules. XP Pharma’s PK assessments and modeling have provided us with important information that has helped us to determine safe and optimal dosing and dosing regimens for our Phase 1 and 2 clinical trials”.

Executive Director ‐ Clinical Development, Pharma Client

Clinical Pharmacology Studies: “XP Pharma Consulting’s knowledge of FDA requirements around clinical pharmacology (drug‐drug interaction studies, CYP450 interaction studies) has helped us to design our Clinical Development plans more accurately by allowing us to incorporate these NDA required studies optimally”.

Executive Director ‐ Clinical Development, Pharma Client

Timely and Detailed Analysis. “XP Pharma is available on short notice and provides timely and detailed analyses. We continue to work closely with XP Pharma as our clinical development programs move forward”.

Executive Director ‐ Clinical Development, Pharma Client

Leading Edge Clinical Pharmacology Support: “XP Pharma Consulting provided leading edge clinical pharmacology and development advice and services that led to several successful IND approvals and the implementation of several clinical development programs. They have also assisted us on translational research programs at pre-IND to IND stage using state-of-the-art modeling and simulation tools”.

Director. Clinical Development, Pharma Client

“High Quality and High Science Plans: Dr. Zhang and her team engaged early and provided rapid, high quality, high science plans and analyses. We really appreciate all of their hard work and advice to our development program. We look forward to continued collaboration and hopefully more regulatory IND and NDA approvals in the months and years to come”.

Director. Clinical Development, Pharma Client