Harsh Thakkar

CEO @ Qualtivate- consultancy helping life sciences to elevate quality management maturity, ensure regulatory compliance, and deploy innovative technology solutions.

In 2022, after working as a consultant for big pharma and having managerial roles in biotech startups, I decided to go all-in on building Qualtivate. 

Qualtivate is a tech-forward consultancy helping early-stage life science companies with QMS, GxP compliance, computer system validation, digital transformation, and data management projects.

Aside from consulting, I love sharing content about quality, consulting, entrepreneurship, and even the occasional meme! My online community has grown like crazy, and the business has too—big thanks to everyone who’s been along for the ride.🙏💙

Why consulting?
Because I get a kick out of building processes and implementing or enhancing systems, working closely with innovative IT and QA leaders. Every new project brings a unique challenge that I find super satisfying to solve for our clients.

My approach to consulting is pretty straightforward. I give my clients three options: 

1) do nothing
2) take my plan and run with it or 
3) bring my team to get it DONE ✅ 

Don’t just take my word, here’s what our clients have to say:

“Qualtivate did a phenomenal job accommodating a last-minute software audit and provided us with a quick audit summary and recommendations.” 
- Project Manager

“Our IT team is going 1000 miles an hour. Glad we have someone like you here to guide them through the compliance checks.” 
- Director of Quality Assurance 

“I appreciate Harsh’s depth of knowledge in computer software assurance and his commitment to quality. He often challenges the status quo and explains his viewpoints in a pragmatic way that is easy to understand.” 
- Sr. Director, Global Compliance

“The automated data extraction app your team built with AI saved 40% of my internal team’s time copy pasting data from Certificate of Analysis (CofA) into our LIMS and other systems.”
- Director, QC and External Quality

“Our client is expecting an FDA inspection soon. When we asked another SaaS company director if they know any QMS consultant, they referred us to you.”
- C Level executive of a SaaS company 

If we sign NDA, I can give you names of above folks.
—-

Oh, and I host the Life Sciences 360 podcast! I get to chat with biotech execs, researchers, and industry experts about their work. It’s all jargon-free and easy to follow. Give it a listen (or watch on YT)—it’s free to subscribe!

—-

For consulting help, message me here or send an email to hthakkar@qualtivate.com

Want to come on the podcast as guest? Or talk about speaking engagements, brand partnerships, ads, or sponsorships? 
Email Nikki at npalmieri@qualtivate.com

CEO and Founder– Qualtivate 

Qualtivate is a quality management and regulatory compliance consulting firm helping life science companies make data-driven decisions throughout their product development lifecycle.

How?
Cultivate insights from your QMS data in hours, not days using our technical expertise in off-the-shelf no-code, automation and AI/ML tools.

Build your phase-appropriate quality management system (QMS) that:

• Provides full transparency of product data, processes, systems, and people. 
• Automates performance monitoring and quality management reviews.
• Embeds compliance within flexible, user-friendly, organically built processes.
• Reduces the organization's quality costs by automating data collection, analysis, trending, and reporting.

To find out more about how we can help, please get in touch with me directly on the details below. 

☏ +1-919-213-8737
✉ hthakkar@qualtivate.com 	
Visit ☛ www.qualtivate.com

Inspiring, reimagining, revolutionising, simplifying Education, Mind Sports, Business Training & B-Sports using thinking FUN! OpozO produces Thinking Gymnasiums 99% user imagination 1% game

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Are you ready for change?

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Harsh Thakkar

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