harmaceutical industry is growing exponentially due to the development of innovative therapies and newer indications along with advancements in drug discovery leading to an extensive increase in the number of products launched into the global market. With this growing potential there is also a substantial increase in the number of adverse events or other safety concerns associated with these medicinal products. Regulatory agencies play a vital role in managing and ensuring the safety profiling of the pharmaceutical/medicinal products and have stringent criteria in granting marketing approvals. For marketing their products in the respective regions, pharmaceutical companies need to adhere and fulfill the respective regulatory requirements. Regulatory bodies have detailed their specific requirements both at the regional and global levels for effectively monitoring and reporting adverse events, there by stimulating the need and growth of pharmaco vigilance practices. This can companies escalate their business process onto a global platform, catering their product across the globe.
The Journey of Vigilare
Praneeth Kamishetty, who has an international industry experience and has worked with various companies in the past, always wanted to set a strong foot in the healthcare industry. Since most products were consumed by general population on a regular basis, he believed drug safety segment was an ideal field for him to enter. Thereafter, he and Dr. Suman Garlapati, who has a rich experience in the field of drug safety, pharmaco genomics, regulatory affairs, clinical trials and hold in depth experience in both clinical and industry front and had decided to start Vigilare Biopharma with the motive of improving the quality of life.
After the establishment of Vigilare Biopharma in 2014, they started functioning by helping pharmaceutical, biotech, and medical device companies in expanding their business globally with out any hassle. Since then, the company has been providing expert drug safety, Pharma covigilance, regulatory, compliance, scientific and business consultation services for the global regulated Pharmaceutical, biotech and medical device Industries.
Throwing light on, Praneeth says, “In the field of pharmacovigilance from functional side to technical aspect, we offer all kinds of services. We have a holistic approach when it comes to our clients needs and that includes auditing & compliances aspects with the ever-changing regulatory norms across geographies. In addition to this we offer scientific and business services to our clients”.
Cost Effective Database Solution
“Vigilare Biopharma offers customized database hosting solution that helps manufacturers to face audits with ease.”
Most manufacturers across the globe find it difficult to document the process and follow a traditional approach involving paper based system which during the time of auditing has its consequence and fail to produce necessary information to the auditor. Sensing this, Vigilare Biopharma offers customized database hosting solution that helps manufacturers to faceaudits with ease. Praneeth speaks,“Not many companies offer Database hosting solution because it’s expensive and tough to maintain. On the other hand, most companies these days want to go global. With our cost-effective database solution our clients don’t have to worry about facing audits & compliances whatsoever.” Suman added, “we know the industry needs and ensure to help the industry meet the agencies/regulatory compliance. Safety and Quality are the two sides of a coin and with current fast pace of growth these two important elements must be taken care without fail. We extend holistic services which covers an end to end aspects by keeping our clients with utmost comfort. Most importantly, will extend core support with regulatory audits”.
Needless to say, Vigilare Biopharma maintains utmost confidentiality and committed timeline. They strive to offer cost effective quality services, compliant to all regulatory authorities across the world. Overall, they focus on long term customer relationship, thus offering tailor made services which maintains strict confidentiality and data security at all times.
Vigilare Biopharma initially beginning with USFDA, at presentis into European regulations as well as rest of the world regulatory markets. However, based on the client’s product requirement, they meet regulations worldwide. Also, they have more than 100 employees spread all over the globe. “We want to be omnipresent in the field of pharmaco vigilace and continue our focus on regulatory affairs and clinical trials. In the years to come, we’ll be seeing ourselves in health economics and health analytics,” concludes Praneeth.