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

Quality Compliance and Excellence

Director/ Principal GxP auditor & GMP Consultant

Advanced MedTech Solutions

HEAD Quality & Regulatory (GM-QA/QC & RA)

Sentiss Pharma Pvt. Ltd.

Sr.Manager Corporate Quality Assurance(sterile Opthalmics &Medical Devices) & CMOs  & Compliance.

Associated with Sentiss Pharma as  Sr. Manager Corporate Quality Assurance. 
Responsible For Vendor Qualifications, CML Audit and compliance , CTL/CRO Audit and compliance, CMO auditing, QMS Systems Improvement , Management Representative For external audits at HO and Research Center, Audit Response,Handling of customer complaints ,supporting plant in regulatory audits, Handling of medical device and CE mark drugs.Management of 6 contract manufacturing locations for tablets, capsules and sterile Opthalamic products etc.

Manager CQA(Sterile Ophthalamic ,Medical Devices  & Injectables), QMS Lead Auditor 

Glenmark Pharmaceuticals

Sterile  and Bulk API production and compliance, QMS,  validation , Qualifications( FAT, SAT, IQ, OQ,PQ) regulatory compliance. Taking care of all types of validation such as process validation, cleaning validation, SHS, DHS, Tunnel validation, Filter validation and  qualifications for sterile and Bulk drug equipment and products.Actively leading teams for investigations and Documents compliance.Taking care of all documents compliance and GMP coordination. sterile  and API Facility Qualifications , Handling Regulatory and customer audits at Facility and compliances.

Manager operation, QMS compliance  & Validations(Sterile and Bulk API Operation Team) 

Ranbaxy

Sterile production of Antibiotics, Qualifications and Validation of sterile facility. Equipment Qualification, SHS and DHS validation, process validation, filter validation and cleaning validation, HVAC validation, Water systems (PW, WFI and Pure steam)  Qualification,  Utility (Nitrogen and compressed air) Qualification, Pre and Post simulation study, Fumigation Validation, Smoke studies, QMS Compliance.

Sr. Executive Sterile operation, Validation , Qualifications and compliance

Orchid Pharma

Sterile Operations, Process simulation,  Media fill, Internal Auditing, Compliance and Validation activities. Hazop studies.Training and GMP coordination.

Executive Operations,QMS compliance  & Validations(Sterile API) 

Wockhardt Ltd.

Responsible for manufacturing of sterile products. Documents compliance and Validation.

Officer  sterile Operation & Validation

Nectar Lifesciences Limited

Responsible for manufacturing of sterile API and documentation.

Sr. Chemist in sterile Operations & Documentations

Modern Diagnostic & Research Centre

Biotechnologist and lab chemist

Director QCE Quality Operations & Principal GxP Auditor. 

Experienced professional for Quality operations, compliance and management of quality, safety & efficacy of APIs,  Injectables, opthalmics, tablets, capsules formulation and medical devices.  

Registered Principal Auditor with IRCA UK and QCI India. 

Six Sigma Master Black Belt certification from Expert Rating, Certified QMS professional  from  Expert Rating. Doctorate in Biotechnology , MBA, PGDRA,PGDCR & CDM, and PGDNBT. 

ISO 9001,14001,45001,17025,22000 , 42001 & 13485 Certified Lead auditor and EUMDR trained Professional. Experiance in Management of clinical trials.       

MDSAP Lead Auditor.
Artificial Intelligence Lead auditor.
Medical Devices Lead auditor.

SQA, RQM+  & MQA Empanelled Lead IMS & Principal GxP Auditor.

Help in QMS compliance of customer Buisness.

https://qce.co.in 

 Contact No-+91 9106396200

taplio

The Battle

Harsh Thakkar

Dr. Pushpinder Paul

Followers

Posts

Engagements

Likes

Ready to grow your LinkedIn presence?