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

QRA Medical

Quality & Regulatory Affairs Consultancy Services

Founder - Quality and Regulatory Consultant

The Medtech Podcast

Founder & Host

BioExpert Network

MedTech Expert

The FDA Group

Quality & Regulatory Consultant

Be the Business

Advisory Board Member

AIVF

Quality and Regulatory Consultant

Hegenberger Medical - Transforming postpartum suturing.

UKMEDI - UK Disposable Medical Supplies

Hardian Health

Quality and Regulatory Affairs Consultant

Mphasis

Do you need help legally bringing your medical device to market in the UK, EU or USA? Feel free to send me a message to see how we can work together on achieving this 📧

Using my extensive knowledge of scientific, legal and business issues acquired throughout different aspects of my work, my main role is to ensure the appropriate licensing, marketing and legal compliance of medical devices to make sure that they reach the end consumer safely. 

I see myself as a crucial link between the industry and the general public; as their bridge of trust to ensure that the medical products that they use are of a high quality standard and meet every guideline there is. 

Moving forward, I am always willing to meet people from both the medical and healthcare industry to share their experiences and stories. If you take an interest to what I do or wish to contact me for business and/or other opportunities, please feel free to connect with me

Book a Microconsulting call with me: https://calendly.com/karandeepbadwal/microconsulting

Functional Areas of Focus:
- Medical Devices (ISO 13485, ISO 14971, MDR, Quality Management Systems, Technical File Remediation, ISO 11607, ISO 14644, IQ OQ, PQ, FDA CFR 21, GMP, 510k, IEC 62304, IEC 82304, Complaint Handling, CAPA, Sterilisation, Software Validation, Computer System Validation CSV, eQMS, Article 10(9)
- Regulatory Affairs (RA)
- Quality Assurance (QA/QC)
- Medtech (SaMD, Digital Health, Artificial Intelligence/AI, Machine Learning)
- PRRC (Person Responsible for Regulatory Compliance) 
- UKRP (UK Responsible Person)
- eQMS (Qualio, Greenlight Guru, JIRA, Atlassian, G Suite, Confluence, Mastercontrol)
- Certified ISO 13485 QMS Auditor (CQI/IRCA)
- Certified EU MDR Practitioner (CQI/IRCA)
- UKCA, CE, FDA, 510k, PMA, De Novo

My Content:
- How to build an ISO 13485 Quality Management System: Tinyurl.com/yagnzxm7
- ISO 13485 or ISO 9001 Quality Management Systems: Tinyurl.com/yavjg6kq
- Medical Device CAPA (Corrective Action and Preventative Action): Tinyurl.com/ycqubsba
- ISO13485 V FDA CFR 21 Part 820: Tinyurl.com/y94bkf5w
- How To Obtain A European CE Mark: Tinyurl.com/yxzplrr2
- What is UKCA and UKRP: Tinyurl.com/cus6teyy 
- What is an EC REP: https://tinyurl.com/59durub8

Follow me on YouTube @KarandeepBadwal

Follow my Podcast @The MedTech Podcast: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3

Karandeep Singh Badwal

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