About us

Global Compliance Partners was founded by a team of experts with deep knowledge and expertise in the Biotech and Life Sciences industries. We specialize in comprehensive Quality and Technical Solutions.

Our mission: Partnering with clients to efficiently build technologies, processes, and programs to accelerate affordable treatments to patients.

GCP prides itself in technical excellence, management acumen and quality of service.

We distinguish ourselves from our peers with our ability to build efficiencies in business and technical problem solving. Our team thoroughly understands the compliance and validation needs of clients and implements lean risk based approaches towards all projects.

Apurva Shah - CEO, Global Compliance Partners

Founder and CEO of Global Compliance partners and consultant in validation, BLA support and clinical to commercial readiness planning. Worked with top clients: Amgen, Roche, Novartis, Sanofi, J&J, BMS, Boeringer Ingeheim, BMS, Baxter, Takeda Pharmaceuticals. He has an MBA from Fuqua School of Business at Duke University

Expertise: Process Validation, Audit support, BLA filing, Equipment Qualification, Cell and Gene Therapy expert
Hobbies: Golf, Piano, Ping pong coach, food and fitness enthusiast
Fun Fact: Stood in line for Sushi from 2 am to 6 am

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Gene Lee - VP of Business Development, West Coast

16 Years of experience in Biotech, Cell Therapy, and Pharma (Genentech-Roche, JnJ, BMS, Pfizer, GCP)

Expertise: CSV, FUE, Validation Quality, Program Development, Data Integrity (21 CFR Part 11, EU Annex 11, MHRA, PIC/S), Quality Risk Management (ICH Q9)

Hobbies: Golf, Snowboarding, CrossFit, Hiking, Eating, Spending time with my family

Fun Fact: I have two daughters and they give me purpose

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Michael Beauchamp - VP of Operations, East Coast

Michael has been instrumental in launching GCP consulting engagements and initiatives in multiple markets. Michael has extensive background in CSV, Data Integrity  and equipment validation.

  • Expertise: Temperature Mapping, Facilities and Equipment validation, Equipment Lifecycle Management
  • Hobbies: Skiing, golfing, soccer, music
  • Fun fact: I’ve skydived twice!

 

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Justin Dubinsky - Data Integrity and Qualification lead

Justin has pioneered Data integrity and Validation solutions for some of our top Biotech clients.

Expertise: Equipment Qualification, Computer Systems Validation and Data Integrity
Hobbies: cars, aquariums, travel and hiking with my dog
Fun Fact: Dived into an underwater shipwreck before.

Glenn McCall

Glenn McCall - Equipment Qualification lead

Glenn is an all-round facilities, utilities, process equipment and temperature-controlled equipment qualification expert supporting GCP for all equipment qualification projects.


Expertise: Temperature mapping, equipment validation, utilities, facilities, HVAC, parts washers
Hobbies: snowboarding, rock-climbing, hiking
Fun Fact: Loves all activities outdoor

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Manisha Walia - VP of Business Development, West Coast

Manisha is one of the brightest and best new talents in the industry and known for qualification, process validation and project management services.


Expertise: Process Validation, equipment qualification and Project management
Hobbies: reading, cooking, music, road trips
Fun Fact: cannot wink, whistle or snap my fingers.