Given the latest dynamics in the pharmaceutical industry, and the increasing cost of drug development, the Contract Research Organization (CRO) domain is set to grow further, along with the fact that pharmaceutical companies worldwide are under pressure to replace revenue loss caused by generics, increasing patent expiry, rising disease prevalence, and rising R&D costs.
With this, quality and timelines have become the yardstick for which CROs are being evaluated by their clients today as drug development has become more expensive and complex. This is where Lambda takes cognizance of this fact and trains its teams to deliver accordingly. With 20 years of reliable service, Lambda provides a full range of clinical trial solutions to big pharma, innovator, biopharmaceutical and generic industries.
Lambda has the distinction of being one of the first entrants in North America through its acquisition of the R&D unit of Biovail Pharmaceuticals in Toronto, Canada. This provided us the footprint and impetus to foray into the United States market through the acquisition of another niche boutique CRO (Novum Pharmaceutical Research Sciences) with facilities in Pittsburgh and Las Vegas.
Novum enjoys a fairly enviable reputation of being the front-runner in the Dermatology domain over the last 25 years in the US CRO Industry. It is poised to build upon the same by enhancing its capabilities in the Oncology and Biosimilar Late Phase Clinical Trials domains. Today, the organization has consolidated operations of both its entities under the single umbrella of Novum Pharmaceutical Research Services in the North American markets.
Quality deliverables is something that the company takes pride in and have structured its processes as such that the teams are open to
Inspections/Audits 24x7 in any of its facilities globally.Furthermore, harnessing technological breakthroughs and upgrading all of its IT systems suitably across the length and breadth of its services globally has been our success motto to date. In fact, Lambda is the world's first CRO to effectively adopt a 100 percent paperless EDC platform for BA/BE studies that has been reviewed and certified by all major regulatory bodies worldwide.
“We enjoy an enviable regulatory track record till date. In the last five years, we have successfully faced 60+ International Inspections/Audits by various regulatory authorities globally (USFDA, EMEA, MHRA, EU member states and various other Regulatory Authorities across the globe), over 140+ Sponsor Audits and 1000+ monitoring audits”, says. Bindi Chudgar, Founder and MD at Lambda Therapeutic Research.
“We enjoy having the distinction of all our submitted dossiers being approved till date without any concerns. This instills a lot of confidence in our clientele and augments our repeat business revenues to a very large extent”, she adds.
Robust Scientific Infrastructure
Talking about the company’s competence, Bindi highlights, “We have state-of-the-art infrastructure in place acrossthe globe with exceptionally well-equipped GLP-certified laboratories.
We also have an in-house Medical Innovation team that nurtures new ideas for development of novel therapeutics encouraging pharmaceutical innovation and drug repurposing. The team undertakes ‘Due Diligence’ for complex in-licensing proposals to provide consultancy services and validates concepts for new product development and guides the sponsors on successful regulatory roadmap for the product registration while minimizing overall program burden. They often deal with addressing complex medical, scientific, and regulatory queries, review of dossiers and planning for Scientific Advice Briefing Package submissions”.
With our expanding global footprint, we firmly believe that we are well positioned to achieve the vision of creating benchmarks & shaping the future of the clinical research industry by ensuring quality, reliability, & value-added services
Lambda's renewed emphasis has been on meeting the needs of biotechnology-derived therapies development. The bioanalytical-biosimilar laboratory in Ahmedabad, India, is a cutting-edge, regulatory-compliant facility worthy of meeting the requirements for submission to local and global regulatory agencies, including, but not limited to, pharmacokinetic analysis, pharmacodynamic or biomarker analysis, and immunogenicity assessment, including cell-based neutralizing antibody assays. The company is currently aiming at revenues of $130 million by the FY 2025-26 and growing at a CAGR of 28 percent YoY.
Further, speaking of a robust roadmap ahead, Bindi concludes, “We have one of the industry's finest credit ratings, which speaks much about our financial health. Our vision is to continuously improve and adopt technological advancements which suit the pharmaceutical industry”.
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