Leaders

The pharmaceutical companies, the cornerstone of comprehensive healthcare, is constantly striving to uphold the highest level of regulatory compliance. However, the ever-evolving regulatory requirements often pose considerable strain on pharma professionals, at times even leading to stress-induced health crises. Additionally, people are dying due to the adulterated medicines. Armed with over two decades of experience in pharma and empathy Dr Rupali Paranjape, Founder of Blue Ocean Compliance has set out to modifying this narrative. Dr Rupali’s journey began in a public testing laboratory. Further in her career, she worked across various roles spanning quality control, analytical development laboratory (ADL formulation), regulatory affairs, and compliance. Throughout her career, she observed the stress that pharmaceutical professionals endure, particularly during audits and inspections. She also felt the pain for people dying due to the adulterated medicines. Driven by a desire to simplify this conundrum, she founded Blue Ocean Compliance in July 2020. The firm helps pharmaceutical companies to qualify the regulatory inspection effortlessly through her simple GAP (Goal, Audit, People) framework. Carving her name as Asia’s first Blue Ocean Compliance mentor in the pharmaceutical compliance space, Dr Rupali became a Thought Leader due to her innovative thought process, and with her book, ‘Blue Ocean of Compliance’ which became an international bestseller.

Her TEDx talk, ‘Compliance: A Key to Saving Lives’ had a profound impact on pharma companies and professionals worldwide. With more than 14 awards under her belt,  Dr Rupali’s work has been recognized by prominent industry bodies on both National and International platforms.

With almost two decades in the pharma sector, what have been the defining moments from your professional journey?

Coming from a pharmaceutical background, I have been associated with this industry for over 23 years. I have over 18 years of direct experience working in the pharmaceutical sector. Four years eleven months ago, I started my own company, Blue Ocean Compliance. A critical turning point was when I moved from regulatory affairs to compliance. I had to ensure complete compliance across the manufacturing site. I was the Head of Department for Compliance, responsible for both India and the U.S. sites.

It was my first time stepping into a compliance role, and it completely changed my professional life. Under my leadership, the company passed the USFDA inspection with zero observations (Zero 483s).

Another highlight was when a client I worked with for an entire year passed the EDQM inspection with no-major and no-critical observations. Another case study is that when my client passed the USFDA with no observation, not only once but twice. However, the most amazing moment is when I could see the transformation in the mindset and thought process of people and hence the site.

What inspired your switch to entrepreneurship in 2020 with Blue Ocean Compliance? What was your initial vision?

When I stepped into the compliance space, I noticed that people face immense stress during audits, so much so that some end up suffering from lifestyle diseases, and in extreme cases, even heart attacks. This hit me hard. Ironically, audits also represent major business opportunities for organizations. But what about the people behind the scenes? That’s when I decided I wanted to do something meaningful for pharma professionals.

Another aspect that struck me was the blind trust we place in medicines. I realized that by working a job, I could contribute to one company. But as an entrepreneur, I could create a larger impact. I can contribute in the economy of India by helping pharmaceutical companies to qualify the international regulatory inspections.

I also felt pain that, due to adulterated medicines, many innocent patients are dying. If I could inspire people who are manufacturing the medicines and who are business owners, then it would create a great impact. In 2020, I started my own company with this vision. I authored Blue Ocean of Compliance, which became an international bestseller on Amazon.

As Asia’s first Blue Ocean Compliance mentor, what expertise do you offer pharma companies?

I prepare companies for setting compliance on their end and ensuring readiness for regulatory inspections. I conduct gap assessments on their manufacturing operations and deliver transformational trainings tailored to their needs. I evaluate every department, including Quality Assurance, Quality Control, Production, Warehouse, and Engineering. I help companies develop a Quality Culture, work on the mindset and thought process of people. What sets me apart is my focus on the mindset and thought process of the people with my Blue Ocean Compliance process. I’m proud to share that one of my clients qualified the USFDA audit not once, but twice, with Zero 483 observations. Another client cleared the EDQM inspection with no critical and no major observations.

Which key professional milestones stand out to you and why?

My book is doing incredibly well, not only in India but also worldwide in countries like Germany, the USA, and Bangladesh. That was my first milestone. Following that, I became a TEDx speaker. My TEDx talk aligns with my purpose, and it's titled "Compliance: A Key to Saving Lives". Being featured on the cover page of international magazines like Passion Vista two times, and being recognized as one of the Most Admired Global Indians, was a dream come true.

One of the most prestigious moments was being invited as a guest speaker twice at CPHI and PMEC India, which is the world’s biggest exhibition of Pharma. Recently, I was awarded by The Economic Times, and my story was featured in Bombay Times.

When my very first client qualified EDQM with no critical or major observations, it was a moment of pure happiness. My other client passed USFDA with noobservation twice.

What’s your guiding leadership philosophy and success mantra?

One of my core beliefs is being a lifelong learner. Especially in my industry, understanding guidelines and knowledge without acting on them is meaningless. Another principle I live by is to never give up. Giving back to the community and the world is equally important.

Integrity and honesty are the core values I uphold, both personally and professionally. They are my true success mantra. I also value simplicity. No matter how much success we achieve, we must stay grounded. There’s always a next milestone, a new level to reach.

Dr. Rupali Paranjape, Founder, Blue Ocean Compliance

Dr Rupali Paranjape is on a mission to help pharmaceutical industries reduce the cost due to non-compliance while helping them qualify the regulatory inspections with no observation. She is well-versed in facing International Regulatory Inspections like USFDA and MHRA. A first-generation entrepreneur, from a humble background, she has more than two decades of experience working with Multinational Pharmaceutical Companies. Dr Paranjape is a TEDx speaker, an international best-selling author of her book “Blue Ocean of Compliance” with 14 honours and awards that includes “Most Inspiring Women Leader in Pharmaceutical & Healthcare industry” by The Economic Times award for her remarkable contributions in the Pharmaceutical & Healthcare industry. She helps pharma professionals to transform, increase their competencies, and help them live life with legacy, fulfilment, and abundance.