Services

Regulatory Affairs 

Clinical Research Documentation

• Investigational New Drug (IND) submissions

• New Drug Application (NDA) submissions 

• Clinical Trial Applications for Health Canada

• FDA Meeting Packages

• Clinical study protocols (CSP)

• Informed consent forms (ICF)

• Investigator brochures (IB)

• Case report forms (CRF)

• Clinical study reports (CSR)

• Safety narratives & reports

• Clinical summaries, Integrated safety summaries (ISS), Development safety update reports (DSUR)

• Patient recruitment materials

Preclinical Research Documentation

• Pharmacology (ADME, PK/PD) and toxicity reports

• Safety reports

• Nonclinical summaries