SOLUTIONS

REGULATORY SUBMISSIONS

 

We will write key regulatory documents for your clinical trial applications:

• The Investigator’s Brochure (IB)

• The Investigational Medicinal Product Dossier (IMPD)

 

And can help you finalise:

• The Clinical Trial Protocol

• The Patient Information Leaflet

• The Informed Consent Form

 

We will also:

• Organise and participate in scientific advice meetings with national Competent Authorities and the EMA

• Identify relevant clinical centres, investigators and/or key opinion leaders

• Recommend clinical CROs