Vishalakshi Ganesh Naik

Founder

As regulatory expectations continue to rise across the pharmaceutical value chain, organizations today face a paradox. While global guidelines such as ICH, Revised Schedule M, API GMPs, and data integrity frameworks are becoming more detailed and stringent, internal teams are increasingly stretched—op­erationally, emotionally, and cognitively.

Compliance is no longer just a technical challenge; it is a human one. The real struggle for many companies is not achieving GMP compliance once, but sustaining it without creating stress, inefficiency, or fear within teams.

This is where Quality Solutions has carved a distinct identity—by helping organizations simplify GMP and transform compliance from a burden into a habit.

Leadership Rooted in Experience & Integrity

Founded and led by Vishalakshi Ganesh Naik, Quality Solutions is a GMP consulting, auditing, training, and coaching organization that works across API, formulation, excipient, chemical, cosmetic, and allied industries.

The company supports organizations from GMP setup at inception through certification, strengthens vendor qualification programs, and focuses deeply on quality culture development using a structured top-bottom and bottom-up approach.

Addressing the Real Gap in GMP Consulting

The pharmaceutical consulting landscape is evolving rapidly, driven by digital quality systems, data integrity scrutiny, and increasing global inspections. However, a major gap persists: most consulting interventions focus on documents and deficiencies, not on people and practicality.

Quality Solutions fills this gap by working at the intersection of systems, behavior, and leadership thinking. The firm believes that many GMP failures occur not due to lack of knowledge, but due to misaligned expectations, impractical timelines, over-engineered systems, or under-estimated risks. True to its values Knowledge, Trust, and Responsiveness.

Quality Solutions openly advises clients when project plans are unrealistic, requirements are excessive, or controls are insufficient.

Guided by the belief “Once a client, always our client,” Quality Solutions builds enduring partnerships that extend far beyond project delivery.

A Practical, Global, and Human-Centric Approach

With experience spanning over 500 domestic and inter­national audits, Quality Solutions supports organizations through vendor audits, gap assessments, CAPA remedia­tion, inspection readiness, and system upgrades aligned with national and international regulations. Its consulting scope includes ICH, Revised Schedule M, API and formula­tion GMPs, along with excipient and chemical compliance frameworks.

What truly differentiates Quality Solutions is its ability to translate regulatory language into workable shop-floor practices. “These days, GMP expectations are continuously increasing and putting teams under stress”, says Vishalakshi Naik. “With our Simplify GMP approach, we consciously work to make compliance understandable, achievable, and sustainable”.

Beyond audits and consulting, the company provides ongoing support long after project closure, through mentoring, refresher training, leadership coaching, and readiness reviews, ensuring that improvements do not fade once consultants leave.

The Story Behind the Vision

Vishalakshi Ganesh Naik began her career in 1988 as a microbiologist and progressed to plant head roles while working with organizations such as Raptakos, Boehringer, Nicholas, Serdia, and several mid-sized companies.

In 2007, when entrepreneurship, for women was challenging and the quality consulting space was still evolving, she shifted her vision toward GMP consulting. Drawing insight from global consulting literature at the British Council Library, she consciously built a practice grounded in structure, ethics, and long-term value.

Her journey was further strengthened through executive programs at ISB (2013 & 2025) and IIM Bangalore (2023) under the Goldman Sachs–sponsored 10,000 Women Entrepreneurs initiative, shaping Quality Solutions into a focused, purpose-driven enterprise.

A Company Powered by Purpose & Diversity

Today, nearly 90 percent of the Quality Solutions team comprises women professionals who bring deep technical expertise and a passion for global quality standards while benefiting from flexible work models that allow long-term career continuity. This diversity translates into empathy-driven consulting, sharp regulatory insight, and strong client relationships.

The Road Ahead: Culture, Capability & Global Reach

Going forward, Quality Solutions’ roadmap is anchored in transforming quality culture. The “Simplify GMP” mission focuses on ensuring that compliance is not threatening but easily understood, by establishing GMP habits, enhancing the thinking patterns of executives, and closing behavioural gaps that often impede efficiency.

Looking ahead, Quality Solutions is focused on strengthening vendor qualification frameworks across global supply chains, delivering end-to-end GMP setup from inception to certification, and building a strong quality culture through habit formation among top and middle management.

Quality Solutions stands apart by turning GMP from a regulatory obligation into a sustainable habit—building cultures where quality truly thrives.

As Vishalakshi Naik succinctly puts it:

“Quality is not an event. Quality is not a department. Quality is a habit”.