The CRO market, in India as well as oversees, is poised to grow significantly in the coming years. Some of the major factors contributing to this growth include recently introduced regulatory requirements to support the global expansion of Indian manufacturers. In recent decades we have been heavily investing in R&D to bring newer molecules to meet global challenges and evolving demands. With newer molecules comes newer ways to ensure compliance with regulatory regimes worldwide. The increasing awareness about the need for a robust regulatory environment has encouraged Indian players in this field to invest heavily to bring their capabilities on par with their global peers. To add to it, the advancements in analytical technologies is helping us understand the effects of our compounds in a never-before-seen manner. Data that was cost prohibitive to obtain now lies within our grasp. In India, the CRO market as a whole is expected to touch $2 billion within the end of the decade, and this growth will present a huge opportunity and incentive for newer investments to meet the demands of not only Indian manufacturers but also global manufacturers.
While there are numerous players cropping up in this domain, one of the leading issues lies between small and large customers is the fragmentation of capabilities amongst the various laboratories which creates issues in coordination leading to missed timelines and increased budgets. A leading name in this industry, Bioscience Research Foundation recognized this problem early on and focused on creating an end-to-end service to ensure a hassle-free process for its clients. “We are amongst the largest CROs in the country with over 150,000 Sq ft of lab space, 300 scientists across ten departments, A dedicated animal science facility, and over 500 instruments capable of meeting all the pre-clinical needs. When we started, our focus was on the Agrochemical vertical; however, in recent years, we have expanded into Pharmaceuticals and Medical Devices. In addition, we have recently established all the capabilities to create a separate Extractable and Leachable study division. As a company, we have never shied away from exploring new avenues of services as we understand that science is evolving every day, and we need to be ready for it proactively”, speaks Dr. C. Tamilselvan, Managing Director.
“We are proud and happy to say that we are amongst the few who can take up almost all the pre-clinical studies under one roof. Furthermore, with globally recognized certifications, we have also created the ability to cater to clients' needs from any country. Another problem clients have is getting service after the completion of the study. However, this is not an issue with our clients as they can approach us years after the study, and we will answer their questions and meet their requirements to the utmost satisfaction”, Dr. C. Tamilselvan adds.
Promising a Gamut of Services
With cutting-edge technology, large lab space, and highly trained staff, we can obtain and maintain over ten national and international accreditations such as OECD GLP, AAALAC, NABL, and more. BRF can offer niche services in all areas of service. With its data being globally acceptable, the firm is confident of its abilities to offer
a one-stop solution where all pre-clinical studies can be conducted under one roof. Increasing reliability and accuracy of data while also saving time and money for our clients.
“We are proud to have a fully equipped facility that caters to all preclinical needs. In addition, we have a well-diversified set of experts enabling us to focus on several verticals such as Pharma, Agro-Chemicals, Medical Devices, Extractable and Leachable, and more. We keep ourselves updated with all the new guidelines across the world. However, suppose it is the case where the new guideline requires an instrument we don't possess. In that case, we have a policy where we immediately start the process of procuring it and adding that capability for the benefit of our clients.
We also constantly invest in automation and newer versions of instruments, this ensures our data has the highest levels of accuracy and our lab's capability to take up a large number of studies remains ahead of the competition”, shares Dr. Tamilselvan.
Vested Focus on Quality
With over 300 trained scientists from all levels across ten departments, these departments are, in turn, led by those with decades of experience in their respective verticals. Their vast experience, combined with the robust training programs for our recruits, creates a solid foundation to take up any challenges thrown our way.
Today, BRF operates on three foundational aspects -Acceptability: BRF’s data is being used for product registration worldwide. The firm is proud to have around ten different certifications to ensure our data is valid anywhere; this also means that we have a strong quality department that provides that the methods are accurate and compliant with the required regulatory regime; Timeliness: With 300 scientists and a large state-of-the-art laboratory, BRF can take up many studies simultaneously. With constant investment in automation systems, it has cut down the processing time on the instrumentation side. With their vast experience in conducting various studies, BRF has been able to standardize study methodologies, ensuring reduction in errors and the time taken for analysis; Affordability: With the capacity to offer all studies under one roof, BRF can offer a lower price per study to our clients, which translates to a direct cost saving.
“We believe in the long-term and personal association with our clients. It does not matter to us if the sponsor is a large or a small player; we spend time with them to understand their needs and guide them on the best course of action. Even after the data submission, we immediately reply to all the queries the regulatory bodies have. Even if the study concluded years ago, we would ensure prompt replies. We extend this facility free of charge even if the client has queries on data from other labs. We do this to ensure our clients solve their problems as soon as possible”, mentions Dr. Tamilselvan.
Charting the Path Ahead
Bioscience Research Foundation has had phenomenal growth since the inception. The firm has been amongst the few labs which was able to get its OECD GLP certification for over seven different departments on the very first try without any major comments, which is a rare achievement for a young lab. “When we first got our GLP certification, we had about 30 scientists. Now in a short span of time, we were able to grow to over 300 scientists, and many the original people are still with us. While our initial focus was on agrochemicals, but now we have expanded to serve clients from Pharma, Medical devices, Drugs & Cosmetics, Biosimilars, Food & Feed additives, and Nano products and have currently 250 clients in over 50 countries”, says Dr. Tamilselvan.
We are proud and happy to say that we are amongst the few who can take up almost all the preclinical studies under one roof
The market is set to grow by leaps and bounds in the coming years. Globally, there is a growing awareness amongst the public about the contents of the products they interact with. Companies, in turn are also equipped to understand the evolving nature of consumer demands. All this when combined with emerging applications for Artificial Intelligence in new molecule development. As a result, we can see an increasing number of products hitting the market in the coming years. In addition, strong regulatory regimes mean that CROs should be ready to step in and provide all the necessary services for the manufacturers.
To keep up with the growing demands, Bioscience Research Foundation has already started stepping up. This year alone, BRF has doubled the available lab space, while the firm is building a state-of-the-art facility on a sprawling 4-acre campus dedicated only to its animal science division, and is has also established a large Radiolabel facility. With more expansion plans in the pipeline, Bioscience Research Foundation is ensuring that the firm is future-ready for all challenges that might come their way.
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