Visual capabilities

Our expertise

The consultants of J&S Preclinical Solutions support your preclinical drug development programs. We can assist you with designing, executing and reporting your preclinical pharmacology studies and toxicology studies. We strongly believe that the integration of toxicology and pharmacology readouts early in the development program is an asset that will strengthen and accelerate your drug development.

J&S Preclinical Solutions has a strong background and experience in assisting small and mid-size (biotech) companies to bring their program to the clinic from proof-of-concept study to GLP toxicology study and preparation of the regulatory dossiers. Our experience covers a variety of target indications, such as oncology, autoimmune diseases, CNS, and metabolic disorders. Furthermore, we have experience in small molecules and biologicals, such as therapeutic enzymes, monoclonal antibodies, bispecific antibodies, ADCs, gene therapy and CAR-T cells.

 We pride ourselves in our ability to think outside of the box and to have a problem-solving attitude. Every program is unique, and we like to bring the most appropriate solution for every problems encountered.

J&S Preclinical Solutions is your partner in designing, executing and reporting preclinical pharmacology studies and toxicology studies, but has also extensive experience in writing the nonclinical sections of INDs, IBs, NDAs and BLAs. If your program requires expertise that we do not posses, we can help you get in contact with other specialists from our network.

 

J&S Preclinical Solution is your partner for the following services.

  • design and implementation of a fit-for-purpose preclinical drug development plan
  • design of preclinical and nonclinical studies
    • proof of concept studies
    • pharmacokinetic studies
    • nonclinical toxicology and safety studies
  • support in organizing preclinical and nonclinical studies and choice of CROs
  • monitor outsourced studies
  • review of the study reports provided by the CRO
  • prediction of safe starting dose in First-In-Human clinical trials
  • support MABEL approach and PKPD model development
  • evaluation of preclinical dossiers
  • writing the nonclinical sections of INDs, IBs, NDAs and BLAs

 Contact us to discover how J&S Preclinical Solutions can advance and accelerate your program.

 

Contact us