Founded in 2010, we serve global leaders in the pharmaceutical, biopharmaceutical, biotechnology, medical devices, chemical, and food and beverage industries. Our objective is to help organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement, and effective change management. Visit us at: https://www.brevitas.us/

1. Biopharmaceutical Chemical
Serving Global Leaders in the
Pharmaceutical Food & Beverage
Industry since 2010

2. An expert team of 70+ consultants with formal education in engineering
and science-based disciplines coupled with knowledge & experience in:
Project management
Operational efficiency Organizational change management
Compliance Technical assurances

3. PROJECTS DELIVERED
7%
7%
25%
42%
19%

4. ENGINEERING
PROJECT
MANAGEMENT
IT PROJECT
MANAGEMENT
COMPUTER
SYSTEM
VALIDATION
DATA INTEGRITY
Capital Project Planning,
Execution & Controls
ETOP, PM & Calibration
Plans
OUR SERVICES
SDLC Program Design &
Implementation
Vendor/Solution
Selection & Deployment
Cloud/XaaS Validation
Program Design &
Implementation
Risk-Based Approach
For Lean CSV/CSA
Execution
Audits & Gap Assessment
Development
Remediation & DI
Sustainability Framework

5. COMMISSIONING,
QUALIFICATION
& VALIDATION
REGULATORY
AFFAIRS
TRAINING
Automation System
Validation
Process & Cleaning
Validation
FUE & PCS Validation
Quality Systems Design
& Implementation
Operational
Improvements
Operational Readiness
New License Application
Inspection Readiness
License Conformance
LMS Design, Selection &
Implementation
Custom Training &
Leadership Development
OUR SERVICES
QUALITY,
COMPLIANCE &
OPERATIONAL
EXCELLENCE

6. BIOLOGICS CDMO
C&Q of HVAC Systems, Clean Utilities, downstream
processing equipment for a facility expansion consisting of
Cleanrooms, UPS and DSP processes
IT Infrastructure Qualification
Overall C&Q Project Management of different consulting
firms
Scope
Protocol development and execution using a risk-based
approach, modularized test documents and leveraging
methodology
Interface definitions and co-ordination to facilitate division
of system boundaries among different consulting firms
and multiple vendors
Phase delivery approach by unit operation to meet timeline
Project Outcome

7. Conduct data integrity (DI) gap assessment on legacy packaging
& manufacturing units and bring them into compliance with DI
requirements for the US and EU markets
Scope
Infused CSV & DI culture to Engineering, QA, and production
during and post project execution.
Established an efficient process of implementing changes and
integrating industry best practices to Client’s operational
ecosystem.
60 legacy manufacturing and packaging equipment were
remediated with no further DI compliance issues in 2 years as
part of this improved program
Agile Team that was flexible to improvise day-to-day operations
with Client to implement changes and execute project activities
to meet requirements
Project Outcome
PCS DATA INTEGRITY
REMEDIATION PROGRAM

8. Integrated approach of IT cloud infrastructure
qualification, LIMS implementation and validation for a
global contract lab
Scope
Risk-based approach to FRA that uses the new FDA CSA
framework that significantly reduced burden to validation.
Use of unscripted and scripted test approach to reduce the
burden of protocol development in order to focus on
testing rather than document generation
Modularized test scripts to enable limited regression
testing requirements for future site deployment
Maximized use of Vendor documentation
Project Outcome
LIMS IMPLEMENTATION

9. Implemented a qualification program for Shopfloor
Automation/Process Control Systems for a leading Medical
Device manufacturer
Scope
Developed policy for qualifying Shopfloor
Automation/Process Control Systems based on outcomes
from risk assessments and computer system assurance
approach
Provided modularized testing templates for qualification
lifecycle documents to reduce validation cycle time
Validated multiple systems of different complexities based
on GxP criticality assessment
Developed a training program for client personnel
Project Outcome
SHOPFLOOR
AUTOMATION VALIDATION

10. Developed a Quality Management System (QMS) for a
software provider of Cloud-based Platform Solutions (MES,
DH & EMS) for Pharma Manufacturing and other regulated
customers
Scope
Developed a Quality Manual, associated policies, and SOPs
to manage quality and maintain state of compliance.
Developed and implemented an agile software development
lifecycle program aligned with CI/CD practices.
Conducted risk-based Vendor Qualification on for critical
hardware and software components as part of the solution
qualification package.
Recommended automated testing approach to ensure
continues compliance and reduce the validation burden.
Project Outcome
SOFTWARE DEVELOPMENT
LIFECYCLE PROGRAM

11. CLIENTS AT A GLANCE

12. CLIENTS AT A GLANCE

13. CLIENTS AT A GLANCE

14. “TIME MANAGEMENT,
TRACKING, CAPEX DELIVERY”
“PROFESSIONALISM,
ACCOUNTABILITY, LEADERSHIP”
“PROJECT LEADERSHIP,
QUALITY RESOURCES,
TECHNICAL EXPERTISE”
“VALUABLE TEAM MEMBER”

15. “OUTSTANDING, DEDICATION,
WORK ETHIC, COMMITMENT”
“COMMITMENT TO
MEETING THE SCHEDULE”
“QUALITY RESOURCES,
ON-TIME, RELIABLE, COST-
EFFECTIVE, SUPPORTIVE”
“KNOWLEDGEABLE, EXPERT
SERVICES, GREAT
CUSTOMER SERVICE”

16. brevitas.us 1 (844) 312-7337
Suite 300-2530
Meridian
Parkway
Durham, NC
27713
Beaver Creek
Business Park
Suite 24-70 East
Beaver Creek Road
Richmond Hill, ON
L4B 3B2
U.S.A Office Canada Office