Due Diligence is focused on the acquisition of a drug substance/product, the acquisition of an entity involved in the development, manufacturing and/or testing of a drug substance/product, or the acquisition of an entity directly involved in conducting clinical trial studies. This process requires an examination of associated corporate/facility records and of associated drug substance/drug product development, manufacturing, or testing records.
Although Due Diligence for drug substance/drug product projects is more commonly requested and conducted by clients early in the development phase, Due Diligence is beneficial for clients when it is applied to all aspects of business operations and GxP activities. The level of Due Diligence applied is important across all phases of drug product development and manufacturing, and clinical investigation.
Our Approach
RegDev’s Due Diligence activities are conducted precisely and objectively by our consultants in an open, transparent, and confidential manner, working closely with the client’s management team and the third party. The phases of Due Diligence project work that RegDev engages in exclusively for its clients include, but are not limited to, an initial screen phase, a high-level evaluation phase, the setting up of a full due diligence team (if required), a data review phase, an on-site or remote visit phase, and a reporting phase.
OBJECTIVE REVIEW
CONFIDENTIALITY
GXP COMPLIANCE
GXP GUIDANCE DOCUMENTS
INTERNATIONAL STANDARDS
GOVERNANCE AND OPERATIONS
INTERACTIVE PROJECT MANAGEMENT
Our consultants take on a highly interactive Project Manager role with our clients. The consultant works closely with the client to identify team members who will actively participate in or support the Due Diligence project activities. The consultant also works to define the scope of the project, develop a plan and timeline, confirm identified resources, and execute the project. By taking on an interactive project management role, RegDev ensures successful evidence-based Due Diligence outcomes for its clients.
EVIDENCE-BASED EVALUATION
Our consultants use evidence-based methods to objectively evaluate and confirm the accuracy of the data and information supporting the scope of the Due Diligence project. This evidence helps confirm for a client that a third-party’s business operation and associated processes/systems, and/or the drug substance/product are thoroughly evaluated and considered acceptable to control product quality, quantify any associated risks, and confirm value.
BENEFITS AT ALL PHASES
The level of Due Diligence applied is important across all phases of drug product development, manufacturing, and clinical investigation. Conducting Due Diligence for early drug product development and early clinical phase activities is recommended for clients from a business-risk perspective. Including Due Diligence throughout helps ensure that the initiative is considered acceptable from a patient safety perspective and by regulatory authorities.
Team Member Insight
“The approach RegDev takes to perform due diligence is an in-depth review and assessment of all parts of an organization to ascertain risks and formulate appropriate risk mitigation steps.”
