Welcome to
KarinJorga Life Science Consulting
Competence in Drug Development
We offer specialized drug development consulting with deep expertise in Clinical Pharmacology.
Meet Karin Jorga
 „My passion in life is to make a difference and to do things differently.”
Karin Jorga, PhD, is a seasoned expert in drug development and clinical pharmacology with over three decades of experience spanning leadership roles in major pharmaceutical companies, including Roche and Genentech.
As the Founder and CEO of KarinJorga Life Science Consulting, she specializes on strategic clinical pharmacology guidance for pharma and biotech firms, focusing on early-phase development, pharmacokinetics/pharmacodynamics (PKPD), modeling and simulation, and pediatric drug development. She has deep and recent regulatory experience through interactions with FDA, EMA, MHRA and others.
Known for synthesizing complexity into clear frameworks, Karin quickly establishes credibility and inspires collaboration. As a consultant she combines expertise with creativity and helps clients turn scientific innovations into future medicines.
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Our Services
Understanding Clinical Pharmacology is essential for optimal dosing of all patient groups.
CLINICAL PHARMACOLOGY PLAN
- Gap analysis for Clinical Pharmacology package
- Strategy to integrate nonclinical, DMPK, PKPD and clinical data with modeling approaches
- Outline a cost-effective regulatory-compliant plan
REGULATORY EXPERTISE
- Negotiate the Clinical Pharmacology Strategy with regulators (eg FDA, EMA)
- Module 2.7.1 and 2.7.2. strategy and writing
- Clinical Pharmacology sections of the prescribing information (drug label)
TROUBLE SHOOTING
- General project review
- Clinical Pharmacology advice on formulation bridging, drug-interactions, food-interactions, ethnic bridging, dosing in special populations etc.
DRUG DEVELOPMENT PLAN
- Fact-track early Development Strategy
- Modeling & Simulation Strategy
- Pediatric Development Strategy
DUE DILIGENCE
- Risk Assessment prior to investment decisions
- Identification of potential show-stoppers
NETWORK
- Extensive network of modeling and drug development experts, leveraged as needed
CONTACT
Let us explore how we can help you!
A well-planned Clinical Pharmacology strategy can enhance the drug label and will save time and costs.
We help you to find the best solution for your project.
Contact
Working with us is easy. We are just an email or phone call away.
Aeschengraben 29
CH-4051 Basel
Directions
Our office is in the center of Basel, the major Life Science hub in Switzerland. It is just a short walk from the central train station Basel SBB.