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

Viatris

Director, Global Document and Change Management

Global Senior Manager, Document and Change Management

Currently oversee Change Control, Document Control (SOP and Site Master File), Manufacturing Batch and Packaging record review and issuance, Quality Compliance (laboratory specifications and methods adherence to Regulatory and Compendia requirements).  Previously oversaw Supplier Management and Quality/Technical Agreements and CAPA program. Active participate in numerous Health Authority Audits and participated in the remediation of FDA Warning Letter.

Senior Manager - Quality Compliance

Mylan

Managed the site CAPA program across multiple site departments (production operations, laboratory, maintenance and engineering and quality).  In addition, managed the site trending assessment program and assisted with the review of post market complaints.  Participated in Health Authority Audits through document requests, scribing and auditor interviews.

Manager, CAPA

Performed independent evaluations of quality systems and practices at Mylan sites across the network taking into considerations national and international regulations as applicable (FDA, EMEA, TGA, Health Canada, WHO, JP).  Assisted in the evaluation of global compliance metrics to determine trends and opportunities for continuous compliance and quality improvement.  Identified potential compliance risks and coordinated resolution.  Provided guidance on quality/compliance improvement as needed to assure sites are prepared for Health Authority inspections.  Prepared and maintained schedules, meeting agendas, and evaluation reports.  Prepared executive summaries and reports based on evaluations conducted.

Manager, Global Quality Compliance

Managed the Regulatory Quality Compliance group which entailed regulatory change control, quality control documentation and LIMS management.  Oversaw projects at various levels for compendia updates, laboratory and/or company initiatives, regulatory requests to ensure Mylan stayed in compliance with EU, JP, CA, AU, NZ, US, SUPAC, CFR, WHO and ICH regulations and guidelines.  Was the site liaison between Regulatory Affairs and Operations for the transfer of new product launches for the US, EU and CA.  Also, managed the quality review and approval of Manufacturing Process Validation and Laboratory Method Validation protocols and reports.  Participated in Health Authority Audits through document requests, scribing and auditor interviews.

Manager, Regulatory Quality Compliance

Managed the transfer of responsibilities of the change control system from Regulatory Affairs to Quality Assurance.  Implemented an external change control system that helps facilitate changes that affect Mylan's global subsidiaries and/or affiliates.  Assisted in the validation of an electronic SOP system within Documentum.  Worked with Mylan’s Quality Control Department to approve and implement a new LIM system utilizing LabWare.  Also assisted in the implementation of a Quality Operations cabinet within Documentum.  Participated in Health Authority Audits by working with document requests and auditor interviews.

Associate Manager, Quality Assurance Change Control

Regulatory Affairs Associate

R&D Chemist

Wyeth

QO Specialist

QO Chemist

Experienced Manager with a demonstrated history of working in the pharmaceuticals industry. Strong professional skilled in Good Document Practice (GDP), CAPA, Investigations, Change Control, Validation, GxP, and GMP.

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The Battle

Harsh Thakkar

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