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

Catalent Pharma Solutions

Quality Engineer

Tandem Diabetes Care

Quality Assurance Specialist I

Stevens Institute of Technology

President of WIP club

• Met and greeted prospective and newly admitted master’s students at Stevens events, including Graduate Open Houses and new master’s
• Assisted in calling campaigns for newly admitted master’s students for recruitment purposes
• Answered questions from newly admitted master’s students, in person at recruitment events and by telephone

Graduate student Ambassador

• Assisted over 10+ new graduate students in their academic transition into Stevens institute of technology
• Provided with information, support, and encouragement they needed to be successful at stevens
• Connected students with their department students 
• Developed improved communication and crisis intervention skills, and gain an increased 
awareness of diversity

Peer Mentor

Vijaya pharma

•	Contributed to the development and implementation of quality systems for a range of medicine & medical device including diagnostic equipment & medicines
•	Conducted root cause analysis and implemented corrective actions for quality issues, resulting in a 40% reduction in customer complaints
•	Worked closely with manufacturing, Sales & Marketing team to ensure quality requirements were met throughout the product lifecycle and determining how to increase sales
•	Trained and mentored junior Associates on quality systems and regulations

Pharmaceutical Distribution Manager

Nefrons hospital

• Dispensed pharmaceuticals and related items necessary for safe and appropriate patient use of nephrological treatments
• Provided medicine counseling, drug information and drug dosing to the patient and their family members
• Applied FDA standards surrounding medication use

Hospital Pharmacist intern

Cipla

• Calculated Dissolution time of tablet with minimal error using dissolution test apparatus following GLP, reviewed deviations

Formulation intern

Maneesh Exports 

• Assisted in Manufacturing, Quality and Packaging areas of Amoxicillin tablet following the Good Manufacturing practices
• Reviewed QA documents such as SOP’s, Sampling reports & Change control for successful validation

Manufacturing Intern

Hello My LinkedIn Family,
My name is Shalaka Naik. I graduated from Stevens institute of technology Major in Pharmaceutical manufacturing engineering. Prior to my masters I had my undergraduate degree in Pharmacy. I’ve got an experience of 4 years as a pharmaceutical distribution manager at Vijaya Pharma, distribution firm in India where we used to distribute medicines & medical devices to patients, hospital, and other pharmacies. Managed a team of 15 with a set goal of improving the efficiency of distributing pharmaceutical products complying the FDA Regulations. After having this experience, I was keener to learn about the big picture Supply chain and Quality of which I was a small part off. I worked at Tandem Diabetes Care as Quality Assurance Specialist and currently working at Catalent as a Quality Engineer 👷‍♀️Here I feel satisfied seeing my contribution touches the patient life in one or the other way. So, Let us contribute our bit to make the world a better place!

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