Castle Validation Services

The goal of our services is to aid our clients in attaining and maintaining compliance with the applicable FDA, MPA, EMEA, Health Canada and ICH guidelines.  As the federal and international regulations governing the manufacture of bulk solutions, drug substance, sterile drugs, and medical devices are both growing and changing at an ever increasing rate, we stand ready to meet these challenges nationally and internationally. 

Our Business

Since our founding, Castle Validation Services has provided services to companies located throughout the United States.  Whether providing equipment/utility/ control system qualification, commissioning, consulting, overseeing process validations, generating procedures or implementing cleaning validation programs, Castle Validation Services can meet your expectations, along with assuring compliance to all federal or international regulatory agencies.

Who We Are

Our staff has extensive knowledge of numerous bio-pharmaceutical manufacturing processes (sterile and non-sterile), automated computer control systems, laboratory and information systems, as well as medical device manufacturing. In addition, to this validation experience, Castle Validation Services possesses extensive expertise in commissioning, design and systems development, and project management. Our reference lists of clients include experience with equipment validation, utilities validation, facilities qualification, cleaning and process validation, project management, computer and control system validation and software validation.  We are proud to possess some of the industry's best knowledge on cleaning validation methodology and program implementation.