Harsh Thakkar

Qualtivate

Clients who have trusted our expertise:

- Rho Inc
- ICON PLC
- Immuneering
- G1 Therapeutics 
- Seres Therapeutics 
- and many more since 2022

Our why:

Help life sciences elevate their quality management and build innovative technologies to make data-driven decisions throughout the product development lifecycle.

4 ways we deliver value:

1. Quality Management & Compliance 
2. Computer Systems Lifecycle Management 
3. Data Governance & Integrity 
4. Custom App Development 

How we can help you:

- Auditing your software and quality systems.
- Prepping sites for GMP.
- Full management of your computer systems.
- Qualifying infrastructure and equipment.
- Training for FDA and regulatory audits.
- Oversight of all GxP QA activities.
- Building smart AI and no-code apps.
- Shifting from paper to digital QMS.
- Moving from validation to software assurance.
- Managing your external suppliers network.
- Crafting a solid data governance strategy.
- Building data-driven supply chains.

How to get in touch?

1) Word of mouth via our happy clients and business partners.

2) Or good old email and phone:

📞 Call us: +1-919-213-8737
📧 Email: hthakkar@qualtivate.com
🌐 Visit: www.qualtivate.com

CEO and Founder

Life Sciences 360

Life Sciences 360 is a podcast and YouTube channel that educates anyone on challenges, trends, and insights in the life-sciences industry. 

As the host, I interview subject-matter experts, CXOs, business leaders, and key life-science partners contributing to bringing new therapies to patients worldwide. 

I'm passionate about advancements in life sciences and technology and always eager to learn from guests— making the show both informative and useful for the audience.

Podcast Host and Producer

Cytokinetics

Associate Director Quality Assurance GxP Electronic Systems

Bristol Myers Squibb

Sr. Manager Quality Assurance- GxP Systems

Manager Quality Assurance GxP Systems

White Collar Technologies, Inc

Consulted for 
- Millennium Pharmaceuticals (acquired by Takeda)
- Biogen
- Myonex (formerly Myoderm)
- Merck
- Johnson & Johnson (led projects for JnJ Consumer, Janssen and Ethicon)

Senior Quality and CSV Consultant

Dr. Reddy's Laboratories

Regulatory Affairs Specialist

Pfizer

QC Analyst

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

A few years ago, I noticed a recurring big hairy problem in the life sciences industry: 

(hint: it's not what you think!)

Companies drowning in data but starving for insights.

I saw teams spending countless hours sifting through spreadsheets, chasing down reports, and still missing critical information when it mattered most. 

Compliance felt like a burden rather than a built-in strength.

I knew there had to be a better way.

That's why I founded Qualtivate.

We started with a simple yet powerful idea: 
Integrate quality directly into everyday workflows and technology. 

No more patchwork solutions or endless manual processes. 

Just streamlined, intelligent systems that turn messy, unstructured data into clear, actionable insights.

Today, we've helped 15+ life science companies transform their approach to quality management. 

By automating workflows and connecting systems, we've not only reduced manual efforts by up to 65% (stats collected by QC lead from a top-25 biotech client) but also empowered organizations to make smarter, faster decisions with confidence.

Just imagine having all your critical data at your fingertips, processes that adapt and improve continuously, and a team that's freed up to focus on innovation rather than administration.

That's the future we're building at Qualtivate.

Are you ready to leave outdated practices behind and embrace a smarter approach to quality and compliance?

Let's make it happen together.

👉🏼 Connect with me or visit qualtivate.com to learn how we can elevate your quality management to the next level.

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

Iovance Biotherapeutics, Inc.

Associate Director, QA Compliance

Senior Manager, Quality Systems and Compliance

Manager, Quality Systems and Compliance

Audentes Therapeutics

Senior QA Auditor

NAMSA

QA Auditor

Captek Softgel International

Providing support and motivation to quality assurance technicians while maintaining close collaboration with mid to senior level management proved to be challenging. However, this challenge is what allowed me to maintain high vigilance to compliance and regulations within our production area. Investigative efforts, interdepartmental collaborative working, and fact based conclusion is the key to obtaining true root causes and robust corrective actions/preventative actions.

Quality Assurance Team Lead

California State University, Long Beach

Currently processing and analyzing pollen for cultural resource management research. Additionally, I am working as an archaeological crew chief in Chiapas, Mexico. My job and responsibilities are dedicated to a research project directed by Dr. Hector Neff.

Archaeological Research Assistant

Titan Medical Enterprises

My first look into the nutraceutical industry at the manufacturing level, I was challenged to resurface my knowledge and experience with chemistry and it's power in qualitative and quantitative analyses. Wearing several hats, I occupied the position of a lab tech, incoming inspection specialist, QC manager, and even forklift driver when necessary. Developing imperative and much needed processes and procedures proved to be successful. 

Never would have guessed to be awarded employee of the year during my short stay. Very grateful for this opportunity.

Quality Control Laboratory Manager

Ellis and Associates

Lifeguard

Ulises Villavicencio,ASQ CQA

taplio

The Battle

Harsh Thakkar

Ulises Villavicencio,ASQ CQA

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