Vijay Kshirsagar

Director

The pharmaceutical regulatory landscape is constantly evolving with stringent compliance requirements. Companies often find it difficult to interpret global regulatory guidelines, and many consulting firms focus on fault-finding, highlighting non-compliances, and issuing lengthy audit observations. However, these reports often fall short of providing actionable solutions. In many cases, internal teams may lack the training or tools needed to perform comprehensive risk assessments, leading to gaps in preparedness. Additionally, identifying current risks, while also anticipating potential future risks, is a complicated task.

TRAC Pharma Consulting stands out in pharmaceutical consulting with its practical, solution-oriented approach to regulatory compliance (USFDA/MHRA/EU/EDQM/ WHO etc). The company offers hands-on guidance through effective training, regulatory services, and auditing & compliance services. It includes gap assessment, gap redressal, preparing for inspection & sustaining the regulatory approval continually through periodic reviews. The focus is not only on telling what to do but more on how to do it. The team comprises retired industry professionals with decades of real-world handson experience. These experts understand the nuances of pharmaceutical manufacturing, quality control, and regulatory expectations.

By leveraging this expertise, TRAC Pharma Consulting offers not just consulting but also mentorship and provides detailed documentation reviews related to the entire Pharmaceutical Quality System. The company places a strong emphasis on risk identification, not just the visible risks of today but the potential threats of tomorrow. It specializes in guiding companies to understand the existence of risks and how to mitigate them effectively.

Fostering a Culture of Ownership Data Integrity

Data integrity and transparency are major concerns in regulatory submissions, and it is important to instill a solid understanding of data integrity within the company culture. It depends on personal responsibility, which is not just about following the company’s rules and completing the training. Once this mindset of the employee transforms, 90 percent of the issues related to data integrity are addressed. It can be done through announced inspections, part-time inspections, and programs aimed at creating ownership. The moment ownership is there, they will take it as their job, not just because the company has the SOP and training.

TRAC Pharma Consulting endeavours to convince them and create a sense of belonging toward the principles of data integrity. Clients should consider the potential of integrity before employees join the company. The organizations should implement thorough checks on candidates before recruitment and provide insights on how to conduct these evaluations. By focusing on these principles, the organization will be able to cultivate a workforce that values data integrity as a fundamental part of their professional identity.

Guiding Companies for Regulatory Compliance

TRAC Pharma guides not only big and medium companies but also small ones in their green field projects, creating required infrastructure/facilities & good quality/ regulatory setup. “We hand-hold out clients in every step of the process, for instance, making submissions, witnessing the regulatory inspections as a Consultant & responding to the agency in a convincing & comprehensive manner”, highlights Vijay Kshirsagar, Director, TRAC Pharma Consulting.

Many Formulation companies, for instance, lack a good understanding of the API (Active Pharmaceutical Ingredient) manufacturing process. The blanket reliance on the dossiers submitted by API manufacturers can pose a significant risk. If that API manufacturer undergoes inspections and the agency uncovers an issue, then it will affect the formulation company too and could lead to massive setbacks. This is not a concern related to only small companies but also many large firms. TRAC Pharma Consulting believes in complete hand-holding to close the knowledge gap and improve compliance in general. The pharma industry is the most dynamic industry, being good today is no guarantee of being good tomorrow.

Raising Pharma Standards in India & Beyond

TRAC Pharma Consulting provides services to several clients across India, China, Bangladesh, Malaysia, Turkey, and also a few companies in the US and Europe. New Schedule M (close to WHO GMP norms) is posing a challenge to small & medium Indian companies. TRAC Pharma Consulting is involved in conducting training programs on revised Schedule M on its own and also as a part of AIPAC (All India Pharmaceutical Association Consortium).

“Our dynamic DCGI, Dr Rajeev Raghuvanshi is giving us all the required support & guidance to AIPAC. While our companies take so much care for export to developed countries, unfortunately, it is not so for our own Indian customers. New Schedule M is going to address this gap. But SMEs need a lot of help which AIPAC is trying to provide. AIPAC has already conducted 5 programs in different parts of India. Many more are in the pipeline”, signifies Vijay. Also to note, Vijay is closely associated with AIPAC for this noble cause.

Furthermore, Vijay is also the Founder & President of SPDS (Society for Pharmaceutical Dissolution Science), a not-for-profit organization. SPDS is the brainchild of Dr L. Ramaswamy, Chairman of Sotax India Pvt Ltd. SPDS has now become a global platform. TRAC feels proud of its association which is helping global industries to develop bioequivalent products, safe & effective.

TRAC Pharma Consulting looks at its consulting & training efforts more as an opportunity to give back to the Pharma industry, through Vijay Kshirsagar's wide and welldiversified experience of around 50 years. It covers a wide range of formulations (nonsterile & sterile) and APIs. TRAC Pharma Consulting was also associated with a project to convert the existing Cephalosporin manufacturing facility into a General block and get it approved by MHRA for the first time in India, a huge and difficult task.