China Preclinical Consulting offers expertise in managing nonclinical programs to support the development of new pharmaceuticals and the safety assessment of chemicals and novel food ingredients. We are specialized in managing the outsourcing of discovery and preclinical studies, such as toxicology, safety pharmacology, PK/ADME and pharmacology, to leading CROs in China. Being based in the middle of action in China, we are able to provide you the independent assessment, in-sight understanding and flexibility to meet the challenges of your fast moving discovery or preclinical project.
Here are some of the typical services offered by China Preclinical:
REGULATORY TOXICOLOGY
Develop non-clinical development plans;
Prepare or review nonclinical documents (e.g. IND, CTA, NDA) for regulatory agencies (FDA, EMA);
Preparation for meetings with regulatory authorities. Accompany clients to meetings and prepare regulatory responses;
GLP study auditing.
PRECLINICAL PROGRAM MANAGEMENT
Manage all aspects of
Pharmaceuticals and Medicine Manufacturing
The Drugs and Medicine industry involves research, development, manufacturing and distribution of pharmaceutical drugs and medicines. Companies in this field focus on preventing and treating illness using medicinal compounds and therapies.
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