Project Management
Regulatory
- We are Subject Matter Experts in Regulatory process and project management in the broader Life Sciences industry
- Delivering tailored customer-centric services on time and according to the highest quality standards
- We apply the latest GxP regulations and provide process optimization opportunities for process with technical backgrounds and limitations of applications. Our multidisciplinary team works according to best practices and proven project management and implementation methodologies such as PMP, AgilePM, V-Cycle, SDLC, BPM
- We support your regulatory and quality projects from initiation to closure
- We analyze and improve your regulatory processes to deliver business value
- We enhance the overview of your regulatory organization through dashboard visualizations
- We optimize (cross-)department collaboration with the applicable content and data management tools and processes
The Challenge
Regulations become more and more complex in today’s world, but also for the regulator it is hard to keep up with new developments in technology (Medical Devices & Diagnostics, Mobile Apps) across the different areas of developing these products and solutions, producing them and getting the feedback from the consumers.
From a digital solution & integration perspective, a divided landscape of different applications is a challenge, as well as cross-departmental collaboration. Regulatory needs input and collaboration with different (if not all) departments within a company.
In order to deal with these complexities, companies require both robust processes and supporting technologies.
Integration of acquired companies
- Into one operational regulatory and quality department by:
- Developing project transition plans
- Managing project execution
- Monitoring and controlling timelines, budgets, quality and risks
- Closing all project deliverables successfully and creating best practice guides
- Establish regulatory intelligence to meet global and local requirements
Risk management
- Identification of compliance risks
- Analysis of the identified compliance risks
- Development of risk mitigation strategies and plans
- Supporting implementation and follow-up of the mitigation plans
Implementing efficient regulatory operations
- Analyzing and mapping regulatory processes
- Identifying process gaps, challenges and opportunities for improvement
- Designing new and improved processes
- Creating transition plans
- Implementing and follow-up of transition plans
Data integration across the product lifecycle
- Analyzing regulatory data and system landscape
- Collecting, cleaning, enriching and transforming the data
- Automating and optimizing data flows
- Defining relevant regulatory metrics and Key Performance Indicators
- Translating data into valuable insights by designing and implementing dashboard visualizations
- Ensuring dashboard continuity by providing appropriate training and technical documentation
Digital solutions & IT tools
- From process investigation, understanding to the applicable solution and toolset
- Regulatory Information Management & Collaboration across Regulatory lifecycle
- Certified ‘VEEVA Vault preferred partner’ for the VEEVA RIM suite
- E2E support from inception, investigation and configuration to validation, Roll-Out and Migration
- Definition and implementation of performance and decision visuals based on, a.o. product submission and registration data
Regulatory & quality writing
- Regulatory documents writing (CTD, PIPs, etc.)
- Quality documents writing (policy, SOP, training, etc.)
Relevant business case