Regulatory Affairs

Providing clarity in regulations to accelerate your clinical trials.

ARI’s regulatory affairs department has experience in working under the regulations of Canada, USA, Europe and Brazil. Our clinical operations have been audited successfully by the US (FDA Division of Scientific Investigation) and Brazilian (ANVISA) authorities.

ARI has filed more than 200 CTA applications on behalf of sponsors for studies conducted at our facility in Canada. We can offer our services for complete CTA preparation or provide guidance to a sponsor. We closely monitor the comments and updates from Health Canada to ensure they are taken into consideration for future submissions, ensuring the fastest possible approval times.

We have experience in filing INDs and NDAs to the FDA on behalf of sponsors. Our experienced medical writers can put together your entire IND package including the Investigators’ Brochure.

We provide full regulatory and scientific consultation services, and our regulatory and scientific experts have attended on behalf of sponsors’ pre-IND/CTA, end of Phase-I, end of Phase-II, pre-NDA/NDS, and other types of meetings in the USA (FDA), Canada (Health Canada), and Europe (EMEA, CPMP, MHRA).