Gap Assessment is a crucial element for identifying weaknesses in current processes, practices, and systems. By conducting an in-depth evaluation, organizations are enabled to address areas of non-compliance and improvement opportunities to achieve the lifecycle state they desire for their product.
During the Gap Assessment process, any gaps or disparities will be identified, and risk-based, phase-appropriate solutions will be developed. This approach allows for lifecycle development support of your product at any phase and includes oversight of third-party vendors. We ensure that any new process or solution that is offered will be sustainable, enforceable, manageable, and scalable.
Our Approach
RegDev’s approach is risk-based and phase appropriate. Our seasoned consultants will work with your team to assess current practices, processes, and systems in place from a GxP perspective, and can support your drug development lifecycle in any phase.
IN-DEPTH EVALUATION
IDENTIFY PAIN AREAS
GXP COMPLIANCE
DRUG DEVELOPMENT LIFECYCLE
RISK-BASED APPROACH
PHASE APPROPRIATE
INCREASE SUCCESSFUL OUTCOMES
By partnering with RegDev, clients are supported with subject-matter expertise and highly effective practices and processes. This allows our clients to meet submission timelines, achieve successful audits and inspections, and improve working relationships with and performance from third-party vendors.
Team Member Insight
“From our experience, gap assessments can be particularly helpful during early development phases, as the company’s quality systems are evolving, when the assessment can provide recommendations for both remediation of current quality systems (if required) and also provide the “road map” for the mid- and long-term development of the quality systems. Gap assessments are also recommended at later stages of development, in order to assess the readiness of the company and its vendors for NDA submission and subsequent pre-approval inspections”
