Life Sciences Solutions

Driven by the need to address critical issues within a rapidly growing sector, the life sciences industry is focused on leveraging its IT systems to significantly improve and expand its resources. RCM is a recognized national leader in regulatory compliance services providing a broad range of consulting and management services to pharmaceutical, biotech and medical device manufacturers.

RCM supports its clients’ regulatory compliance efforts with comprehensive expertise in Part 11, pharmacovigilance, computer systems validation and qualification, lab equipment and process control validation as well as enterprise application software implementation. RCM’s Life Sciences Practice (LSP) specializes in regulatory compliance and information technology support for the pharmaceutical, biotechnology and medical device industries. LSP services are specifically designed to mitigate risk and reduce time to deployment.

Our clients benefit from:
• Knowledgeable and team-oriented project managers and analysts
• An ability to approach virtually any technology with expert personnel
• A “brain trust” type of environment that can assist with almost any question in the realm of computer validation, Part 11, and computer system testing
• A customized approach to meet individual client requirements
• Clear, well-organized, and defensible SOPs, validation reports, testing reports and other documentation to meet the most stringent regulatory requirements

The following diagram depicts the areas of the drug development and delivery life cycle that RCM supports with its various service offerings. Immediately proceeding Discovery, RCM maintains a complete suite of services aimed at supporting the needs of its clients.