Preclinical: IND/CTA Enabling

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Accelerating your drug into first-in-human trials in the USA and Europe requires the completion of an investigational new drug (IND) and clinical trial application (CTA), respectively. Both the FDA and EMA have different regulatory requirements, Abzena have the know how to meet this important milestone.

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IND & CTA Enabling Expertise

IND- and CTA-enabling studies comprise of preclinical pharmacology and manufacturing studies. These allow you to submit a formal application with either the FDA or EMA. We accelerate the development of your medicines, de-risk your program and reduce time to market by leveraging the extensive experience of our scientific and regulatory affairs experts.

We design and deliver tailored solutions across a comprehensive suite of services including, cell line development, formulation, analytical method development and process development.

Preclinical IND/CTA Enabling Services

Preclinical activity is conducted through all phases of drug development. Therefore, we recognize that this activity needs to be fully integrated into a regulatory-driven, collaborative drug development strategy. With over 20 years of experience in drug development, we offer specialized preclinical IND/CTA enabling services.

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