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50 Leading Companies of the Year 2021

In Conversation with Hema Lakkaraju, HAYAG CORP Founder and CEO: ‘Our Mission is to Provide a Platform for the Health and Life-Sciences Industry to Accelerate Product Launches through compliance strategy’

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“We believe that health and life sciences innovators need a strategic regulatory framework to thrive.”

HAYAG CORP, a compliance consulting and software company, assists health, life sciences organizations to streamline their compliance by offering superior, value-added, and professional solutions to complicated regulatory concerns.

The company’s mission is to help clients develop, implement their strategic data-driven compliance frameworks and practices to improve the agility, efficiency, and efficacy of their companies’ competitive efforts.

HAYAG was incorporated in 2019 and is headquartered in Pleasanton, CA.

Hema Lakkaraju, HAYAG CORP Founder and CEO, spoke exclusively to The Silicon Review. Below is an excerpt.

Tell us about your services in brief.

HAYAG brings in regulations customization and strategy for projects, products, and organizations:

HAYAG PROD+: Software that provides customized strategic regulatory controls, policies, and procedures for health and life-sciences products under minutes.

HAYAG PROJ+: Software that provides customized strategic regulatory controls for health and life-sciences organization projects such as HR, R&D, finance, operations, IT, and manufacturing.

HAYAG ALM: Complete ALM solution, which includes compliance assessments for product, projects, risk management, vendor management, document management, team management, and task management integrated into the lifecycle management.

HAYAG Consulting Services: These unique strategic data-driven consulting services help organizations build compliance frameworks, saving organizations 50 percent of time and cost.

Q. What do regulators think of RegTech?

RegTech is often seen as an operational solution. We are entering a new era where RegTech can build bridges connecting the silo regulations knowledge and provide us with a strategy, customized product design, procedures, not just automating operational and maintenance of documents and CAPAs.

Q. How do automating compliance tasks help in reducing operational risks?

We are now in an era of ever changing technology, digitization, and regulations. To meet this ever-changing factors/ecosystem, we need to smartly automate compliance tasks, save operational costs, time, and provide strategy.

We have silo skills of regulations in the workforce, which is costing organizations time and money. This can be solved through strategy and automation, which provides transparency, great collaboration, and increased performance.

Q. What motivated you to reinvent the compliance management segment?

For years being a quality and regulatory professional for startups and organizations, I saw frustration, resentment, and whatnot. Importantly, being a support system of teams rather than part of them. I asked myself, why? What can we do to serve better?

After discussing with team members, I realized that QA/RA professionals are performing as blockers, not as accelerators towards product launches. We are not trying to understand a project, product but endlessly talking about regulations, implementing processes with little effort on understanding products, projects, and/ or any situation.

I founded this startup with a mission to provide a platform for the health and life-sciences industry to accelerate product launches by truely understanding products, its technology, and its data.

There is one more big challenge for the teams—silo regulations skills in the workforce. This brings in confusion, delays, frustration, and one of the biggest reasons for delayed product launches in the innovative health and life sciences industry. This is due to technology, digitalization, and integration like digital diagnostics, combination kits, etc.

I can see and feel the emerging need for a new generation of regulations services where strategy, understanding technology, and a holistic approach can bring high value and high performance for regulatory efforts.

Q. Developing compliance solutions for healthcare needs the support of high-level talent and dedication. How did you manage to form your dream team?

Our team is unique, containing people who share the vision of strategic data-driven compliance, understand technology, cybersecurity, privacy, and other life-sciences regulations. We came so far in bringing these solutions to customers with a team of great designers, developers, architects, and strategists.

Q. Trust is a difficult attribute to measure and a delicate dynamic to maintain. How do you maintain this with your clients?

We believe that the clients deserve smart, strategic solutions, and you should be available when needed. We take extra effort to understand products, projects, and customize solutions, services specially designed for clients. We believe that each organization is different, has different challenges, unique products, and different milestones. That’s the reason customized regulatory solutions matter a lot.

What are your trajectories for the next five years?

We seek to expand to Europe and Asia. Be a leader and trusted provider for strategic data-driven regulatory services for innovative health and life sciences.

The Leader at the Helm of HAYAG CORP

Hema Lakkaraju, founder, serves as the Chief Executive Officer of HAYAG CORP. She is an advocate and implementer of the data-driven compliance models for the health and life-science industry. She has been in this industry for over 12 years, helping organizations with data, risk, and product compliance.

Hema has been working with different teams, organizations on a data-driven risk, and compliance strategy framework. She founded HAYAG with a vision to help guide the innovative health and life-science industries on data-driven compliance and risk management.

“We came so far in bringing solutions to customers with a team of great designers, developers, architects, and strategists.”