Biologics

Unlock the Potential of Biologics

The preclinical phase of the development of new biologic medications can present several challenges. KreaMedica’s 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.

Unique Challenges within the Development of Biologics

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 submission.

KreaMedica’s Solutions for Biologics

KreaMedica provides strategic advice for a wide range of molecular modalities based on the accumulated knowledge of its team of experts.
KreaMedica provides competent, affordable, uncomplicated support for clearly defined and time-limited projects.
KreaMedica can create additional capacities and gain specific skills from an experienced team of Nonclinical experts for short- or medium-term projects.
KreaMedica assists in the justification of the appropriate species for the preclinical program.
KreaMedica designs assays to support the unique requirements of your drug development program.
KreaMedica assists in the selection of suitable CDMOs and CROs.

Contact KreaMedica, if you…

are a startup company 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 discuss their development approach with regulatory authorities.
want to discuss your needs in toxicology and nonclinical safety assessments.

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 accustomed to talking to people at all levels. I make toxicology understandable to you, your stakeholders and the regulatory authorities.

Truth in Numbers

110+

Development Programs

70+

Sponsors Who Trust Us

73+

Years Combined
Industry Experience

Testimonials

Don’t take our word for it.

James L. Ellis, Ph.D.
Nocion Therapeutics, Inc., Chief Scientific Officer

They provided valuable insights and recommendations while seamlessly integrating into our team.

I have had the pleasure of working with KreaMedica on several programs. They proactively identified and addressed issues and provided regular updates to ensure everyone was on the same page. Their attention to detail and willingness to take ownership of the project’s success makes them invaluable partners. They are great to work with, and I would highly recommend them to anyone looking for a drug development partner.

Brian Jones
Respirion Pharmaceuticals, Chief Operating Officer

KreaMedica was an essential complement to our virtual team.

They supplemented and filled in gaps in our internal network and worked well with our advisors. They truly wanted to contribute to and be part of the project’s success. I highly recommend Claude, Poulomee, and Rudi as reliable partners for planning and executing toxicological and bioanalytical projects.

Ron Wolff
RK Wolff Safety Consulting Inc., Principal

The combination of all their perspectives made a tremendous difference.

I have worked with KreaMedica for many years, and I must credit them for the team’s talent, professionalism, and chemistry. That doesn’t happen by accident. As a consultant, I rely on them as the first line to monitor studies and provide proactive solutions when required.

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