Dr. Suman Garlapati, CEO
"Can you give it in writing that your antidepressant causes sedation?" This request by a lady on the phone got the call center of a drug manufacturing company worried. In the next few days, the drug company learned that the same lady had filed a million-dollar lawsuit against them, citing the sedative side effect of their antidepressant pill. The company knocked on the doors of 3R Biopharma to have their name cleared of this allegation. When 3R Biopharma put its foot on the ground for investigation, things started to unravel. The plot was that the lady had met with an accident, and she blamed the antidepressant pill for the incident. 3R Biopharma recorded the time of the accident and the exact time when the lady had consumed the drug. As per the provisions in the existing laws, 3R Biopharma got in touch with different people and obtained the lady's medical records. In the course of the investigation, the firm established that the drug's metabolism and influence lingered for only five hours, but the accident occurred almost 10 hours after the pill was consumed. Based on the findings, 3R Biopharma prepared a report and submitted that to the client's attorney. Lo and behold, the drug company came out winning. It was proven that the lady was driving under the influence of alcohol which led to the accident, not because of the medicine she took.
For any business, if trust is lost—everything is lost. And this applies more to pharma and healthcare businesses. 3R Biopharma, with its scientific acumen, attention to detail, and value-driven client engagement strategy, has wowed its clients since its inception. Take, for instance, the case of 3R Biopharma's another client that had to initiate a product recall. The bigger problem, however, was that the recall procedure was done hastily and the case was closed. Subsequently, the FDA, in its routine checkup, found several lacunae in the handling of the incident, and the drug company was in a soup yet again.
Driven by core values of transparency, safety, integrity, and quality, 3R Biopharma keeps safety at the forefront of its decision making
The firm carried out retrospective activities and gathered all the data around product quality complaints and filed FDA reports. "We brought to bear the best practices in pharmacovigilance (PV) and filled the gaps to ensure the client was back in the market with their products on the store shelves," says Dr. Suman Garlapati, CEO of 3R Biopharma.
The immense success of 3R Biopharma is because of its simple tenet that reads: "PV practices are necessary, not an accessory. Just as common salt is essential to cook any food, PV practices are crucial for pharma products, biotech products, veterinary, medical devices industry, and hospital vigilance. And continuous product monitoring is the need of the hour for improved healthcare delivery and better brand performance." Based on such principles, 3R Biopharma offers four core services: drug safety (pharmacovigilance), clinical trial monitoring, quality compliance and metrics, and regulatory affairs. Besides, the firm specializes in medical-legal assessment and scientific writing and can handle product recalls and management.
3R Biopharma also covers PV quality assurance services, where it handles clients' reports, ensuring that they comply with all the FDA requirements, including signal detection and assessment reports. It offers a Risk Evaluation and Mitigation Strategy (REMS) program, which the FDA can require for certain medications with serious safety concerns. What's more, post FDA's declaration of submitting reports electronically, the firm collaborated with technology companies and extended a safety database solution to clients. The database has enabled them to submit reports electronically. "We help firms manage 24/7 medical call center activities," says Dr. Garlapati. Aware of the fact that one size doesn't fit all in PV, the company stresses attention to detail and standard operating procedures (SOPs) to deliver greater value to clients.
Driven by core values of transparency, safety, integrity, and quality, 3R Biopharma keeps safety at the forefront of its decision-making.