Regulatory Business Excellence
Optimise your regulatory business operations and improve compliance today
Due to the highly regulated environment that is Life Science and the continuous higher demand to meet quick time-to-market business requirements, Regulatory Business Operations are becoming a crucial aspect on the path towards success.
At BASE, we help our customers reduce the complexity of the Regulatory Business Operations while improving both efficiency and compliance. We help them overcome some of the biggest regulatory challenges today, such as IDMP, SPOR/DADI, EU CTR and eCTD v4.0, through:
Optimise your regulatory business operations and improve compliance today
Due to the highly regulated environment that is Life Science and the continuous higher demand to meet quick time-to-market business requirements, Regulatory Business Operations are becoming a crucial aspect on the path towards success.
At BASE, we help our customers reduce the complexity of the Regulatory Business Operations while improving both efficiency and compliance. We help them overcome some of the biggest regulatory challenges today, such as IDMP, SPOR/DADI, EU CTR and eCTD v4.0, through:
- Business Optimisation
- Data Integrity Assurance
- Regulatory Compliance
Business Optimisation: Create value through process streamlining
BASE offers a comprehensive toolset to increase the speed and effectiveness of any process through the applicability of Lean Six Sigma© methodologies to help customers reduce costs and overheads, improve collaboration and develop capability.
A Lean Six Sigma© process:
- Is faster
- Is more efficient
- Produces greater customer satisfaction
- Results in increased profit margins
Data Integrity Assurance: Quicker to market through data-driven decision-making
As the industry is changing towards more data-driven decision models, there is a continuously higher demand for an integrated regulatory system to enable increased efficiency. At BASE, we help life science companies reduce the redundancy, reduce the number of handovers and reduce the complexity that comes with disconnected systems and scattered data.
Key components of this offering are:
- Data Quality Assessment
- Data Integrity Framework
- Data Clean-Up
- Data Enrichment
- Data Harmonisation
- Data Integrity Monitoring
Regulatory Compliance: Ensure compliance through robust structured data & GxP processes
Stay compliant and become inspection-ready by equipping your systems and processes with optimised best practice solutions. As industry standards and regulatory requirements change, it is crucial to stay competitive and avoid findings or other compliance issues.
We offer solutions in the following areas:
- GxP Audit Preparation and Training
- Standard Operation Procedures
- Key Performance Indicators (KPIs) & Metrics
- Regulatory Intelligence
- Due Diligence & Gap Analysis
- GDPR & Security
Why should you choose our services?
Reduce complexity of regulatory business operation
Ensure compliance through robust structured data & GxP processes
Quicker to market through data-driven decision-making
Create value through process streamlining
Would you like to know more ?
Reach out to our specialists
