QA/QC Consulting Services Summary
Nucro-Technics offers quality assurance and quality control consulting services to organizations that may not have the internal expertise to fulfill GMP requirements or other companies that may just require additional technical support for their operations. This service is cost-effective and ideal for small Canadian and foreign companies that wish to import and distribute their product in Canada.
Services include the following:
- Quarantining, sampling and releasing of Drug products for sale
- Writing and maintaining Standard Operating Procedures
- Reviewing batch documents
- Auditing of vendors and third party manufacturers in Canada, U.S., Europe, Asia and Australia, according to the current Canadian GMP’s and/or FDA Regulations
- Acting as a liaison with the Health Products and Food Branch Inspectorate (HPFBI) during audits
- Regulatory compliance assistance
- Provision of facilities for the storage of retention and/or stability samples
- Preparation and renewals of Drug Establishment License / NHP Site License
- Preparation of Site Master Files
- Adverse Reaction Reporting
- Pharmacovigilance Activities
- Acting as the Legal Agent in Canada
Because the QA/QC consulting services are well-integrated with Nucro-Technics’ lab operations, all GMP requirements from an import and distribution perspective can be met by a single group providing a turnkey service to our clientele.
In support of our QA/QC Consulting and Regulatory Affairs Consulting divisions, Nucro-Technics offers many other services to our international clientele. These services include:
- Providing an address where clients without a Canadian presence can receive any correspondence from Health Canada;
- Providing meeting facilities at our location for the use of our clients;
- Introducing suitable lawyers and notary agents to clients to handle any legal issues;
- Collaborating with clients’ eventual partners, concessionaire agents or suppliers;
- Organizing, when necessary, consent for the importation of material into Canada (ministerial approval, identifying appropriate customs officials and the most convenient customs entry point);
- Representing clients to Health Canada as required, and acting as their representative during Health Canada audits; and
- Storing and distributing, for the Canadian market, niche products that require special handling and attention.