Preclinic Research is a vey wide scientific area where it is essential that the documentation have to be in accordance to regulatory guidelines.

LINK offer nonclinical-support services covering areas of preclinical research and development by providing:

• Knowledge from executing regulatory nonclinical studies in accordance with the latest international nonclinical guidelines as issued by EMA, FDA and ICH

• Expertise about the need for sufficient quality assurance for regulatory acceptance (GLP compliance)

• Expertise in areas as general toxicology from acute toxicity to repeat dose studies, preclinical safety pharmacology and genotoxicity studies

• Design, perform, assess and report regulatory safety biological studies as study director and study monitor

• Advice on regulatory nonclinical documentation required for submission of IND or IMPD (e.g. Investigator Brochure, clinical application/IND)

• Support in safety evaluations of products in development

• Experience from outsourcing biological stand-alone studies and safety programs to international CRO’s