Standard Operating Procedures (SOPs) are documents which provide instructions for how to work, to be in compliance with Current Good Manufacturing Practices (cGMPs) and Good Clinical Practices (GCPs). Since cGMPs are typically implemented for the first studies in humans (including manufacture and testing of the drug substance and product, as well as the conduct of clinical trials), the expectation is that a system of SOPs should already be in place.
Our Approach
Implementation of SOPs starts early in clinical development. Initially, RegDev will perform an assessment of the status of existing SOPs (a “gap assessment”), from the perspective of both the existence of required SOPs and the level of compliance of existing SOPs. We will work with your team to develop a “compliance roadmap” to help you achieve the appropriate level of compliance, both for your current stage of development and to prepare you for commercialization of your product.
RegDev understands the requirements for compliance with cGMPs and GCPs at different stages of development. We can help guide you by establishing the necessary system of SOPs to keep you in compliance at every step of the way, from early clinical development through commercial launch of your product.
COMPLIANT SOP LIBRARY
TAILORED SOPS
GXP COMPLIANT
EASE OF USE
PROCESS DOCUMENTATION
COMPLIANCE ROADMAP
LIBRARY OF COMPLIANT SOPS
RegDev’s library of compliant SOPs has been developed from our experience gained from working with numerous clients – from start-up through to established pharmaceutical companies. We make the implementation procedure as painless as possible for you by working closely with you to tailor each SOP for your company and its operations.
GAP ASSESSMENT
As an initial step, RegDev will perform a “gap assessment” to give us a snapshot of the status of your quality system SOPs. Based on this, we will develop a “compliance roadmap” to bring your systems into compliance, from your current stage of development through to commercialization of your product.
INCREASED UNDERSTANDING AND OWNERSHIP
Throughout this process, we will work closely with your team, both to understand your internal processes, and to allow your team to develop “ownership” for the processes and documentation. From our experience, this significantly enhances employees’ understanding of cGMP and GCP regulations and requirements and improves compliance levels dramatically.
Team Member Insight
“We create tailored and phase-appropriate policies and procedures to support clients on their drug development journey. We don’t overengineer or provide unnecessary policies or procedures that are hard to comply with and adopt.”
