Effective Project Management Helps Alleviate Compliance Issues and Production Backlogs

Effective Project Management

In order to meet increasing demands for their product, our global pharmaceutical client retained the services of the Brevitas consultants to provide project management leadership to resolve resource constraints, scheduling backlogs, and compliance issues.



Area of Expertise

Regulatory Compliance


7 months

Services Provided

  • Project Management
  • Organizational Change Management
  • Production Scheduling


Immediate actions by Brevitas consultants helped prevent additional compliance issues and enabled our client to continue supplying their product to global markets.

Business Challenge

Our client is a leading global pharmaceutical manufacturer that retained the services of Brevitas to implement new processes to help with resources allocation in relation to their production schedules and meet international compliance standards. There were also concerns surrounding their ability to supply products as planned, in order to meet increasing customer demand.

Our Approach

Brevitas consultants approached the challenge by involving a complete lifecycle management of the project and associated change management activities. The consultants started by organizing the day-to-day operations and leveraging constraint theory and lean methodologies. They followed up with regular status reports that identified risks and responded by analyzing corrective actions and change controls on a monthly basis. Throughout the process, consultants facilitated meetings with both internal and external stakeholders and worked with coaches and leaders to gain their buy-in & support.

Results Achieved

  • Organized and tracked the status of over 100 corrective actions and change control documents
  • Provided a clear view to senior leadership on how their departments were performing
  • Created a production schedule that better met demand requirements
  • Implemented process improvements into the production schedule
  • Documented “lessons learned” and created a handover report for future planners

More Case Studies

Untitled design (25)

Airflow Visualization Study to Address Audit Observations

science-7788808_1280 (1)

Validation Framework and Data Integrity Program for CGT Non-Profit Organization

Serialization and Aggregation Project

Serialization and Aggregation Readiness for US Products

GMP Drug Manufacturing

GMP Drug Manufacturing Policy Development

Data Integrity Risk Assessment

FT-IR Instrument Data Integrity Risk Assessment

Autoclave Validation

Autoclave Qualification to Achieve Regulatory Compliance

logistics transportation services

Sortation Code Upgrade Enhances Sortation Functionality & Efficiency

SOp consolidation

SOP Consolidation across Multiple Global Sites Promotes Move towards Lean Operations

Let's Get Started!

Our expert consultants will guide you step-by-step through the process of achieving tangible results and long-lasting improvements.