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Our highly qualified consultants have taken on management positions, such as Quality Director, Quality Assurance Manager and Compliance Specialist for pharmaceutical and biotech companies. Assignments include interim positions until the right employee is hired to fill the role, coaching junior…

The key to having a successful regulatory inspection is Preparation. One of the best ways to prepare your facility for a regulatory inspection from Health Canada, FDA, ANVISA, EMA or any other regulatory agency is to perform a Mock inspection.…

Health Canada, FDA and other Regulatory Agencies have an expectation that companies understand the capability of their systems that generate and store data/records including any data integrity risks associated with such systems. It is important for companies to execute comprehensive…

GMP Consultants are engaged with clients on long term basis from several hours / week to multiple days / week to assist teams with the following tasks (to name a few);

GMP Consultants have supported many large and small Pharmaceutical companies to reduce their Deviation, Change Control, and CAPA backlogs. We also provide training on Deviation Processes and Human Error Reductions to help reduce the number of deviations initiated.