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The development of new biologic medications during the preclinical phase can present several challenges. KreaMedica’s core expert team comprises seasoned immunologists, eminent toxicologists and experienced project managers, who will help you navigate this complex drug development pathway, to overcome regulatory challenges and complexities.

biologics challenges

Unique Challenges Within Biologics

Because our team has been in the industry for so long, we understand that biologics programs have many challenges. The following roadblocks are frequently encountered during the development:

  • Manufacturing processes and formulations are complex.
  • The target interaction is highly specific, demanding well-established cell-based and ligand binding assays and complex analytical characterization.
  • The justification of the relevant species for preclinical toxicology studies must be established.
  • Immunomodulatory components bring in new challenges and analytical hurdles.
  • The regulatory path is lengthy and complex, requiring extensive data to support the submission
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KreaMedica’s Solutions for Biologics

  • Strategic advice for a wide range of molecular modalities based on the accumulated knowledge of its team of experts
  • Competent, affordable, and uncomplicated support for clearly defined and time-limited projects
  • KreaMedica can support you to create additional capacities and gain specific skills from an experienced team of Nonclinical Expert for short- or medium-term projects
  • We assist in the justification of the appropriate species for the preclinical program.
  • We design assays to support the unique requirements of your drug development program.
  • Less can be more – consider single species (or no species at all) and in vitro data
  • KreaMedica assists to select suitable CDMOs and CROs.
  • Our scientific project management approach ensures that all aspects are considered.
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Contact KreaMedica, if you…

  • are a startup planning to pitch and need support for building a nonclinical development plan with robust estimations of timeline and costs.
  • are a biotech company looking for support to advance your projects into clinical development.
  • are a startup/biotech company that wants to get its development approach discussed with regulatory authorities.
  • want to discuss your needs in toxicology and nonclinical safety assessments.
  • are a startup/biotech company that wants to prepare for an audit.
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Team Member Highlight

Meet One of Our Biologics Experts

Jörg Herbst

We collaborate with Jörg Herbst, PhD, ERT, DABT.

Jörg is a board-certified toxicologist with over 20 years of relevant experience in biotech and startup companies in the field of non-clinical development and safety evaluation of biologics. Prior to founding NCMA Consulting GmbH he was leading the non-clinical departments of Molecular Partners, Auregen BioTherapeutics, Morphosys and Apogenix.

I am supporting my clients to bring their assets through the nonclinical phase into clinical development. I’m used to talking to people at all levels. I make toxicology understandable to you, your stakeholders and the regulatory authorities.

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