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Our Partners Services

Pharmaceutical Consulting Services

Quality and Compliance

Preparing and/or performing training on cGMP and ICH guidelines, quality and compliance

Creating new and/or improving existing quality documentation and system such as SOPs, change controls, deviations, investigations, and CAPAs

Creating validation protocols for analytical test method, cleaning and manufacturing process, executing validations and preparing/reviewing validation reports

 

Audit

Performing worldwide third-party audits and qualifications on behalf of pharmaceutical companies such as suppliers of raw materials and components, clinical trials sites, and contract manufacturing

Helping pharmaceutical companies prepare for upcoming regulatory and clients’ audits and prepare professional responses to audits observations

 

Regulatory

Helping pharmaceutical companies in the submission and registration of foreign products in Canada and the U.S. as well as the registration of Canadian and U.S. products in foreign countries

 

Formulation Development and Clinical Studies

Providing reverse engineering and novel formulation development solutions

Providing expert advice on the clinical studies requirements and documentations

Finding proper clinical research sites for the proposed clinical studies worldwide