The global market for pharmaceutical regulatory matters, which was estimated to be worth $13.9 billion in 2022, is anticipated to expand at a CAGR of 8.7 percent throughout the anticipated time frame. As laws for the pharmaceutical industry become stricter and more complex, businesses will face enormous obstacles. The necessity for compliance with international standards emphasizing quality and safety as well as the growing complexity of regulatory regulations are the main drivers propelling the expansion of this market.
The pharmaceutical industry in India has shifted its focus to high-quality standards as a result of the public recognition of India's pharmaceutical production and export capabilities over the past ten years. As a result, there has been an increase in demand for qualified and experienced auditors and businesses that provide services in quality compliance. This has also become the driving wheel for expansion of the companies.
Acuitty Consultant, an ISO 9001:2015 certified company, with a global presence spanning India, China, Canada, and Argentina, is one of the leading companies offering regulatory & supplier qualification auditing services for the pharmaceutical and medical device industry. With expertise and knowledge of evaluation of all six systems, Acuitty Consultant is offering solutions to manufacturers of FDFs, APIs, Intermediates and KSM manufacturers. Acuitty Consultant houses highly qualified auditors trained as per the requirements of stringent regulatory standards. The firm’s global presence has further solidified the team’s knowledge allowing the auditors to have broader insights to cater to the unique needs of the customers.
“Our commitment to being ‘local at heart, global in spirit’ further strengthens our understanding of diverse compliance requirements. This strategic positioning not only grants us extensive local knowledge but also fosters a wide client base worldwide. We are uniquely positioned to deliver exceptional regulatory compliance services with a global perspective.
We are committed to promoting sustainable practices in the pharmaceutical industry. With a strong emphasis on transparency and accountability, we are driving responsible sourcing and ethical supply chains. Together with our clients and partners, we work towards a greener and more sustainable future for pharmaceuticals”, shares Jalpan Upadhyay.
Acuitty’s value system focuses on four core ideas of integrity, ownership, transparency, and adaptability.
As an organized company, Acuitty prioritizes quality standards, meeting the globally applicable and acceptable standards in service, by incorporating these practices into everyday functions. A demonstrated ability and dedication to exceed customer expectations, allow Acuitty to deliver outstanding results.
A Gamut of Offerings
Acuitty Consultant offers comprehensive end-to-end solutions for regulatory compliance pertaining to the pharmaceutical industry. The company is driven to offer high-quality results ensuring that the regulatory compliance standards are met. Through continued support and guidance to the client, Acuitty guarantees a seamless engagement process for sustainable solutions. The team takes pride in its consistency of assigning the best auditors for each task, which assures efficient, precise, and detailed audits. With a global network, the team is able to meet tight deadlines without compromising quality, while also optimizing costs, and delivering value-driven solutions.
With risk-based decision-making being one of the primary components of regulatory consulting, Acuitty follows a comprehensive three-step risk-based decision-making process, which helps clients make informed decisions. The three key steps to this method consist of pre-inspection assessments, thorough audits and evaluations, and post-audit corrective and preventive actions (CAPA). The pre-inspection audits allow the team to scout out potential risks, and tailor the audits accordingly, focusing on the most vulnerable areas. The audits phase allows the team to evaluate multiple verticals like quality systems, procedures, and actual practices which help to identify any potential threats which could impact patient safety. The last step, CAPA, is the phase where solutions to mitigate risks are implemented.
Local at Heart, Global in Spirit
Acuitty’s USPs are its extensive network of experienced auditors, its robust audit library, a completely customer-centric methodology, as well as user-friendly technology platforms. With such facilities and resources, the team at Acuitty has the capacity to serve bespoke solutions to its diverse client base, ensure on-time deliverables, and lend continuous support to help clients meet their compliance obligations effectively. The firm’s philosophy of ‘Simply, we deliver unmatched solutions’ comes from the company’s overall culture.
Beyond the scope of its operations, the firm also has a unique work culture, and operational ideologies which make it stand out from the competition.
“Acuitty stands out from other consulting companies by being market segment agnostic. We embrace collaborations with both emerging and global companies, driven by our shared goal of ensuring a safer pharmaceutical market for all. Our primary focus is on enhancing safety and compliance across the industry. At Acuitty Consultant, our culture promotes individual empowerment and encourages ownership and accountability. Our company values are not just words on a wall; they drive our project delivery and the impactful solutions we provide”, further shares the founder.
Acuitty brings extensive experience and diverse knowledge of regulatory obligations in various nations, allowing the team to offer broader services to the global clientele. Having already established a distinct identity from its competitors and standing at a separate plane, Acuitty is anticipated to only grow in the coming years, taking charge of the industry as a global leader.
Jalpan Upadhyay, Director
With a strong dedication to quality compliance and a mission to streamline supplier qualification processes, Jalpan set out to establish Acuitty Consultant. Leveraging his industry expertise and innovative mindset, he has successfully built a reputable consulting firm that is globally recognized and trusted by clients. Jalpan remains proactive in driving the company forward, guaranteeing its position as a leader in the industry by consistently offering comprehensive and dependable services to clients.