Scitus Pharma Services: Rowing the Pharmaceutical Industry via Continues Innovation & High Knowledge Acumen

A.Rajavel, Managing Director,  Dr. S. D. Rajendran, Head-Operations, Dr. S. Senthilkumar, Head-Clinical Operations  ,R. Karthik, Head-Bioanalytical Operations, A. Raja Vasudev, Head-Pharmacovigilance, S. Kathiravan, Head-Quality AssuranceMany of the world’s population are in desperate need of better medical care. This requirement is a major driving force behind drug discovery’s mission to uncover new medicines. However, the drug discovery process is complex and stubborn. The clinical stage, in particular, is resource intensive, demanding, and involves high risk. This is where Clinical Research Organizations (CROs) come in to assist drug manufacturers on their journey to discover and approve drugs of the future by designing and conducting clinical research in the most scientific way. The trend towards outsourcing to CROs isn’t expected to fizzle out anytime soon, especially as clinical trials are rapidly proliferating across the world.

Scitus Pharma Services Private Limited is one such quality driven contract research organization(CRO), laying its primary focus on supporting pharmaceutical and biopharmaceutical industries in their quest for developing and commercializing NCE and generic drug products by running bioavailability and bioequivalence studies on healthy volunteers and patients Phase II to Phase IV clinical trials, Pharmacovigilance services for the life cycle management of drug products, and In vitro bioequivalence studies. Moreover, the core strength of the firm lies in the committed management that ensures employees on the floor appreciate
management's commitment to quality and practice it in their activities. "Our multiple layers of quality control and quality assurance ensure that our deliverables meet and exceed the quality expectations of clients,” signifies S. Kathiravan, Head-Quality Assurance.

Dr.S.D. Rajendran, Head Operations emphasizes, “We have acquired approval to conduct our business from the Drugs Controller General of India, CDSCO, New Delhi, as well as the Saudi FDA. More importantly, we have been inspected by the US FDA twice, with ZERO483 observations in both inspections.” Scitus Pharma employs multiple levels of Quality Control and Quality Assurance systems in addition to Quality Management Systems, making sure that the systems, processes, and personnel render highquality deliverables. It ensures to deliver highend quality services by leveraging modern analytical equipment that has very high levels of sensitivity and accuracy. Dr. S. Senthil kumar, Head Clinical Operations adds, “The underlying philosophy of Scitus Pharma is to consistently meet our customers’ expectation of quality & project delivery while upholding ethical standards in clinical operations and employing validated methodology in analysis.”

As a quality driven CRO, Scitus Pharma SOPs adhere to the highest standards set by the industry’s best practices and major regulatory expectations around the globe. The firm performs Statistical analysis using the SAS system for Windows version 9.4 (SAS Institute Inc., USA) and pharmacokinetic parameters determined from the time and concentration data using a non compartmental analysis of Phoenix WinNonLin professional software (Version 8.0 or higher). Further, the BA/BE studies conducted by the firm are in an extremely controlled environment and all activities are strictly driven through SOPs. “The studies conducted are approved by the Independent ethics committee, all procedures in clinical and bio analytical divisions are SOPs driven in accordance with current GCP, GLP standards, and applicable regulatory specifications”, signifies R. Karthik, Head Bioanalytical Operations.

Scitus Pharma is currently growing at a pace of 30%, and it intends to expand its business operations in related domains to boost revenue growth even more. Essentially, it envisions to be known globally as the CRO of repute that is synonymous with ethics and quality, offering services for the entire spectrum of drug development in support of regulatory submissions. “Our goal is to attain and maintain the highest quality and compliance standards in all of our deliverables, ensure fast turnaround in our project deliveries and pursue excellence through science and technology,” concludes A. Rajavel, Managing Director.