Regulatory Authority (ies)

Regulatory Authority (ies). Those agencies or authorities responsible for regulation of Bulk Drug Substance in the United States per FDA regulations, in Europe per EMEA regulations, and in Canada per Health Services, Canada. If AVID needs to comply with other agencies, it will be addressed on a case-by-case basis as agreed to in writing by both parties.

Regulatory Authority (ies). The government regulatory entities with regulatory authority over the Manufacture, storage, testing, use or sale of pharmaceutical products (including the Material), as well as any successor entity thereto, limited to the FDA and the EMA