CHALLENGE

As per Health Canada’s requirements, regarding to a sponsor located outside Canada , a scientific or medical officer residing in Canada that represents the foreign sponsor and is responsible for providing an attestation with respect to the clinical trial application or the amendment that is being filed, was required.

SOLUTION

C2C with a team of in-house scientific and medical personnel that can be the representative signatory submitted the clinical trial applications on sponsors’ behalf. C2C also took the role as a Canadian importer per GMP practice requirements.

BENEFIT

C2C, as a Canadian regulatory expert understanding the Canadian medical as well as regulatory environment, can provide key support for the submission of clinical trial applications, New Drug Submissions, or other regulatory initiatives. C2C is an advantage for a foreign sponsor to communicate with Health Canada as well as for dealing rapidly with questions, being in the same time zone as the reviewing regulatory agency.

By understanding Canadian as well as foreign regulatory environments, C2C provided the best strategic initiative for niche products’ timely access to the Canadian market.