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

Revance

IT R&D Systems

Xoriant

Sr. IT Analyst

SUN Pharma

Project Liaison between the Business, Quality, and the Technical teams to identify the user/system requirements and manage the project timeline for systems and their changes and infrastructure components (Documentum, Trackwise, BMC Remedy, BMC BPPM, and Arcos)

Sr. Computer System Validation Advisor

Foresight Group International AG

•	Setup Validation practice at Foresight Group and own Quality Initiatives across the organization 
•	Directed Multi-disciplinary teams on quality procedures in Multi-Million Dollar Pharmacovigilance projects for implementing Oracle Argus Safety at pharmaceutical companies spread across multiple continents using GxP-regulated systems
•	Provided consulting solutions globally for top 20 pharmaceutical companies in the Project Management, Product Development, Management, Support, Computer System Validation, Data Integrity, and Quality Assurance

Practice Owner - Quality and Computer System Validation

Stryker

Led Prospective and Concurrent Validation projects at Stryker Endoscopy, Stryker Communications and Stryker Global Technology Centre targeting USFDA Form 483 CSV remediation

Project Lead - Stryker Endoscopy CSV Projects

Mahindra Satyam

Consulted for large UK Based Life Sciences Institution for executing Validation activities and advised the Projects on IT-related quality issues, regulatory compliance, and client policies and standards relating to IT systems

Global Computer Validation Expert

I am a seasoned IT Advisor, Strategic Thinker, Solution Owner and Avid Learner with over 17 Years of experience in managing multi-disciplinary teams of varying sizes and complex programs of Data Integrity, Quality Assurance, Computer System Validation, Process Compliance, Quality Assurance, Project Management, Business Process Analysis, Process Framework development, Risk Assessment and Profiling, Process Re-Engineering, Reviews, Audits, GxP, Regulatory Compliance against FDA - 21 CFR Part 11 and GAMP 5.0 Framework in Pharmaceutical / Medical Device IT Compliance & Quality environment. 

I have consulted globally for Top 20 pharmaceutical companies and advised in Computer System Validation, Project Management and Quality Assurance in the following Business / IT functions but not limited to:
- Enterprise Resource Planning
- Supply Chain Planning
- Pharmacovigilance 
- Serialization and Track & Trace
- Pack Management
- Manufacturing and Packaging 
- Laboratory Information Management 
- Electronic Document Management
- Electronic Change and CAPA Management
- Electronic Signature implementation for GxP processes
- Data Center and IT Infrastructure Commissioning
- Retirement and Decommissioning
- Quality Management Setup 

I have rich experience in aligning business processes and systems with corporate strategy; ensuring overall IT infrastructure, landscape and roadmaps are integrated and supportive to business; leveraging cloud technology and service models to improve efficiency and reduce total cost of ownership.

I also have broad experience with vendor selection process (RFP), setting up contractual agreements (MSA/SOW), on-premises, and cloud-based software providers; identifying and developing high-quality start-ups and managed service providers for growth and strategic partnership.

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