Activities

One of the many activities performed by GMP Consultants is Auditing. We average 10 – 12 audits / year. We have experts that are qualified to audit sterile and non-sterile drug manufacturers, APIs, packagers, labelers, testing laboratories, importers, distributors and…

GMP Consultants routinely conduct GAP Assessments for clients. They can be general GMP Assessments to ensure that the company meets regulatory GMP requirements or they can be specific assessments, on topics such as Data Integrity, Cleaning Validation, QMS, Analytical Services,…

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…