Ensuring corporate commitments for obtaining and maintaining compliance to cGMP / GMP standards and for ensuring that the consumer’s trust in the product has been upheld.
The Regulatory Affairs Department has been assembled with the focus of combining the scientific, legal, and business knowledge that is needed in order to maintaining both product and facility compliance to law. Requests from clients, along with contractual obligations and advertisement constraints, are considered within the context of the jurisdiction of sale and the finished product’s market authorization.
The following are a few additional subject areas for Regulatory Affairs staff:
a) Facility Licences / Certifications
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Canadian
- Establishment Licence
- Site Licence
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American
- US FDA’s FEI
- ISA for Halal
b) Product Licences
- Canadian – DIN and NPN submissions and licencing maintenance
- American – NDA and ANDA submissions along with maintenance of NDC records
c) Clinical Studies Coordination
- Canadian and US FDA legal requirements as well as compliance with the ICH guidelines
d) Current Knowledge
- an understanding of the regulatory environments and challenges faced by pharmaceutical and nutraceutical industry members
e) Export Documentation
- a wide range of supports: ITCs, Export Certificates, Manufacture Declarations, Animal Tissue Forms, and Prior Notices
f) Legal Documentation
- including but not limited to: Confidentiality Agreements, Quality Agreements, Manufacturing Agreements, Exclusivity Agreements, and Authorization Letters
- client specific technical reviews can be conducted for labels, packaging materials, product inserts, and related advertisements or handouts