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From guidelines to global reach: Regulatory experts’ contribution to medicine

As a regulatory affairs consultant, Manan Shah's prowess in synchronising compliance efforts, maintaining patient safety, and aiding seamless market access has positioned him as a pivotal figure in the regulatory landscape

Published: Tue 29 Aug 2023, 3:49 PM

  • By
  • Shagun Sharma

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In an age marked by rapid medical advancements and global health crises, the role of regulatory affairs experts has come to emerge as a cornerstone in a drug’s journey from pharmaceutical guidelines to worldwide accessibility.

One among these stalwarts is Manan Shah, a regulatory affairs consultant with a diverse career trajectory and impactful contributions that have somewhat reshaped the landscape of the availability as well as accessibility of medicines. Shah has been published in the Asian Journal of Pharmaceutical Research and Development (AJPRD) with a paper titled 'Inspections – Key Role in Quality of Medicines', in the RF Quarterly — a Regulatory Affairs Professionals Society publication with his paper 'Access Consortium – A global collaborative pathway', and multiple other significant international publications in the space of healthcare and regulatory affairs.

In an interview with Shah, we found that his story began with academic pursuits comprising a bachelor in science in biotechnology and an MS in biotechnology with concentration on regulatory affairs from the Johns Hopkins University. It becomes evident that regulatory consultants like Shah are the gatekeepers of innovation. They bridge the gap between the development of groundbreaking medicines and their ultimate accessibility to patients worldwide.

The complexities of the pharmaceutical and healthcare sector cannot be underestimated. Regulatory guidelines evolve rapidly, posing formidable challenges. The path to bringing novel products to market is neither straightforward nor simple. The learning curve of bringing novel products to market is steep and intricate, but his dedication to continuous learning and problem-solving has allowed him to navigate these hurdles and emerge victorious.

By meticulously devising regulatory strategies for import compliance, Shah facilitated the swift access of essential medications to those in need, embodying the profound impact regulatory experts can have on real lives.

The hallmark of Shah's journey is his role as a regulatory CMC (chemistry, manufacturing, and controls) strategist for a biologic product. This role underscored his ability to navigate the intricate realm of health authority expectations, ensuring post-authorisation conditions were met promptly. His work epitomised the seamless orchestration required to align regulations and enable global distribution, thereby bolstering patient safety on a global scale.

Challenges, too, have been woven into his journey. Staying abreast of rapidly evolving regulatory landscapes has been a formidable task. Regulatory guidelines shift unpredictably, necessitating vigilance and continuous education. Shah's commitment to attending industry meetings, conferences, and training programmes reflects his dedication to remaining at the forefront of regulatory changes.

In a world where novel products pose unique regulatory challenges, Shah's ability to navigate uncharted waters has proven invaluable. As a regulatory affairs consultant, his prowess in synchronising compliance efforts, maintaining patient safety, and aiding seamless market access has positioned him as a pivotal figure in the regulatory landscape.

In essence, Shah's journey serves as a microcosm of the expansive role played by regulatory experts. Beyond the confines of guidelines, these experts ensure that medicinal treatments traverse the complex terrain of regulations, reaching individuals in need around the globe. His journey is a testament to the often unnoticed yet indispensable work of regulatory affairs professionals, who champion patient well-being through their expertise, dedication, and commitment to a more accessible medical world.

— Shagun Sharma is a business journalist.



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