Verista: Quality, Compliance and Safety Across the Entire Drug Development Continuum

Manny Soman, CEO
The COVID-19 pandemic has created huge ripples across all industries worldwide. In the life sciences industry particularly, we have seen drugs being delivered to market in record time. In fact, we have proven that the industry can get an mRNA vaccine successfully launched in ten months as opposed to years. In addition to the enormous pressure of getting safe and effective drugs to the market in the shortest possible time, life science companies must also ensure that they comply with the onerous complexities of all the regulations from R&D to manufacturing. Failure to carry out proper validation, compliance, and regulatory activities can lead to potentially disastrous results. Verista is a pioneer in this field, partnering with clients to facilitate compliance and safety across the entire product development continuum. The company provides operational, IT and validation expertise across systems, quality, and data integrity to fast track the drug development process.

Verista sits at the intersection of validation, compliance, quality and regulatory – managing and overseeing the complex aspects of business operations, processes and data integrity associated with these functions. In fact, the company validates and automates operational data from R&D to the manufacturing floor. At the same time, this data needs to be collated for regulatory compliance and the advancement of the product lifecycle. The company’s deep domain expertise enables clients to adhere to regulations at every stage of the drug development lifecycle with the greatest precision, safety, and quality. “We use innovative technology to ensure that our clients’ systems are highly compliant while maintaining data integrity at all levels,” says Manny Soman, CEO, Verista. Having said that, Verista empowers clients to improve operations, enhance quality, reduce risks, and ultimately improve patients’ lives.

Recently, Verista worked with four COVID-19 vaccine manufacturers to help bring their therapies to market in the shortest time possible.
This was because Verista is compliance-focused and could rapidly understand the clients’ data and systems. Importantly, Verista’s agility and focus on data and system integrity made them the partner of choice. “We can use this knowledge and apply it to almost any molecule across the spectrum to provide compliance at all levels, at high speed,” adds Soman.

Verista also enables medical device manufacturers to speed up their time to market. With its dedicated hardware and software testing teams, the company assists clients with product testing prior to the pre-approval stages. The company provides the skill-set to perform rigorous testing of product hardware and software under critical timelines, which are often key in meeting market demand. Case in point: Verista assisted a client to quickly bring at-home COVID-19 tests to market. Working with the client to align various factories with different processes and set up data requests, they ensured all processes were highly compliant. “By paying attention to minute details in terms of medical, regulatory, and political requirements that met the client needs, we enabled them to launch the device in record time to allow people to perform COVID-19 at-home tests,” notes Soman.

Empowering life science organizations to meet regulatory and compliance requirements, Verista plans to introduce an e-validation platform that will work as the gold standard of validation, reducing the number of human touchpoints needed to bring a high level of data and systems compliance quickly. “We are building a platform that will help clients get their end product, be it medical devices or lifesaving drugs, to the market faster,” concludes Soman.



Fishers, IN

Manny Soman, CEO

Verista is a leading business and technology consultancy firm that provides systems, compliance, validation and quality solutions to life science companies enabling them to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing and distribution—bringing together decades of knowledge, the most advanced engagement platforms and transformative technologies. This allows clients to benefit from the ease, efficiency and trust that results from working with one partner who excels across specialties. Verista’s clients trust the company’s 500+ experts to deliver consistent, safe, and high-quality results across the product development lifecycle