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

Lesley Worthington, Coach & Consultant

Professional development support and guidance with a focus on communication skills and relationship management. Providing coaching, consulting, and advice to help you solve your most pressing issues and achieve your professional, organizational, and business goals.

Communication & Leadership Coach for Quality Assurance Professionals

Helping people say what they’re trying to say. And write what they’re trying to write. I work with quality assurance and regulatory affairs professionals in medtech and other industries learn how to speak and write more effectively in the business world. I help people improve their communication skills so that their outside matches their inside and they get the respect and authority they deserve based on their education, experience, and knowledge. I help people remove stress, save time, have effective work relationships, and feel better about speaking and writing at work. I also help people improve their writing (from emails to articles to procedures) so that it is clear, concise, and effective.

Communication and Writing Coach for Quality Assurance Professionals 

Semi-private and small group reading, writing, and critical thinking skills instructor for children age 10 and older.

Writing Instructor

I make sure that your documents, manuals, marketing info, contracts and agreements, procedures, and correspondence are error free. And do what they're supposed to do.

Copy Editor and Proofreader

Qkids

Teaching English to Chinese and Turkish students - ages 3 to 15

English Second Language Teacher

A&C Field Hockey Academy

Involved in the strategic planning, event management, and content creation for a sport academy for elite athletes.
Planned and created content including: website, blogs, social media, and internal and external communications.
Involved in the planning and management of ongoing programmes, tournaments, and special events.
On the organizing committee for the Pan Am Jr Field Hockey Tournament in Toronto in May 2016.

Content Writer

Clinitox Diagnostix

Quality Assurance and Medical Device Manager responsible for all aspects of the Quality Management System (ISO 13485) in a Medical Device company in Canada. Responsible for designing all documents and systems to ensure compliance with all quality and regulatory (Health Canada and USA FDA) matters.

Regulatory Affairs and Quality Assurance Manager

Diagnostix Inc.

Quality Assurance and Medical Device Manager responsible for all aspects of the Quality Management System (ISO 13485) in a Medical Device company in Canada. Responsible for creating the QMS and all documents, procedures, policites, and systems to ensure compliance with all quality and regulatory (Health Canada and USA FDA) matters.

Do you feel that you're the only one who cares about Quality?

Do people think of you as a compliance cop, a firefighter, or the help desk?

Are you trying to build a Quality Culture but are not sure where to start; or face resistance everywhere you turn?

You need to change how you communicate about Quality. 

I can help!


𝗪𝗵𝗼 𝗱𝗼 𝗜 𝘄𝗼𝗿𝗸 𝘄𝗶𝘁𝗵?

• Professionals who feel their communication skills are holding them back
• Quality enthusiasts eager to transform 'Quality' from a concept to a culture
• Leaders needing help to navigate professional roadblocks


𝗪𝗵𝘆 𝗱𝗼 𝗜 𝗱𝗼 𝗶𝘁?

• It’s fun to help people uncover their blind spots! And get unstuck!
• I love helping people connect better with others and with themselves
• It’s exciting to help people get clarity, figure out next steps, and take action


𝗪𝗵𝘆 𝗰𝗵𝗼𝗼𝘀𝗲 𝗺𝗲?

• I don't care who you choose. Shop around. Pick who’s best for you.
• The people who work with me like the fact that they get clarity, make progress, and take action. That's bordering on "transformational", I'd say.
• And they like the fact that I know stuff and that I’m good at helping them.
• I know a lot about Quality, Psychology, Coaching, Law, Teaching, Words, and Entrepreneurship
• Don't choose me if you want me to solve your problems. I don't do that. People come with problems to be solved and through coaching they solve them. I coach people, not problems.


𝗪𝗵𝗮𝘁 𝗗𝗼 𝗜 𝗢𝗳𝗳𝗲𝗿?

The Quality Network (membership)
     • Training, webinars, resources, coaching, networking
     • Members have access to exclusive content and a supportive community focused on communication and quality
     • Join the waitlist

One-on-one coaching 
     • Fully customized
     • Includes programmes for non-native English speakers

Small Group Coaching
     • Communicate Simply and Powerfully 
     • Influence with Impact
     • Build a Quality Culture

Masterclasses
     • Building a Quality Culture
     • Preparing Effective QMS Awareness Training
     • Writing Good Procedures

Corporate training and coaching - Let's chat!
     • Designed for you

Speaking Engagements - Let's chat!

(You can find all of these things and how to contact me by clicking that link right above where it says how many followers I have)


𝗪𝗵𝗮𝘁 𝗱𝗼 𝗽𝗲𝗼𝗽𝗹𝗲 𝘀𝗮𝘆 𝗮𝗯𝗼𝘂𝘁 𝗺𝗲?

• Check my recommendations or book a time to meet me and decide for yourself. 


𝗪𝗵𝗮𝘁 𝗲𝗹𝘀𝗲 𝗱𝗼 𝘆𝗼𝘂 𝗻𝗲𝗲𝗱 𝘁𝗼 𝗸𝗻𝗼𝘄 𝗮𝗯𝗼𝘂𝘁 𝗺𝗲?

• What you see is what you get: simple, genuine, passionate about my work.

taplio

The Battle

Harsh Thakkar

Lesley Worthington

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