Pinak Patel

Founder

The Indian pharmaceutical sector has witnessed unprecedented growth in recent years, propelled by domestic demand and burgeoning export op­portunities. However, this growth has been accompanied by heightened regulatory scrutiny from domestic agen­cies and international counterparts. The aftermath of the COVID-19 pandemic has further accentuated the focus on quality assurance, driving pharmaceutical companies to seek reliable partners capable of meeting global standards. Against this backdrop, RMS Scientific Services has carved a niche for itself by offering comprehensive analytical solu­tions tailored to the exacting requirements of the indus­try. With a keen understanding of the evolving regulatory landscape, RMS Scientific Services is adept at navigating complex compliance frameworks to ensure the highest standards of quality and integrity.

Founded on the principles of precision and innovation, RMS Scientific Services has emerged as a trusted partner for pharmaceutical companies seeking superior analytical methods development and validation solutions. Initially, the firm ventured into the field with a specialization in impurity profiling, which is distinct from method development. Upon the commencement of method development by clients or industries, it often identifies certain unwanted compounds or specific impurities previously undiscovered in its projects. "Clients provide us with analytical data, including mass spectrometry and various forms of nuclear magnetic resonance [NMR], such as 1H NMR, 13C NMR, and GC/GC-MS, and elemental analysis. Utilizing this data, we potentially analyze and deduce impurities or unwanted products", says Pinak Patel, Founder.

As the clients witnessed the reliability of the company’s analyses, they entrusted the company with full project responsibilities, enabling it to initiate method development encompassing various techniques such as HPLC, Dissolution profiling, Ion Chromatography, GC-MS, ICP, and ICP-MS. Subsequently, the scope expanded to encompass a comprehensive range of analytical testing. While RMS Scientific Services offers a breadth of analytical services, its core expertise remains in impurity profiling, the foundation upon which the analytical method development packages are built. Presently, the offerings include chromatography, notably HPLC, GC, and ion chromatography. In addition, the company extends its services to encompass third-party analysis, including NMR, SEM-EDAX analysis, Thermal analysis like TGA, DSC, DTA, elemental analysis, and an expanding array of third-party testing services.

RMS Scientific Services and allied laboratories are committed to compliance with regulatory guidelines, be it those stipulated by the FDA or other international regulatory bodies. The company adopts a nuanced approach, tailoring its processes and protocols to align with the specific requirements of each client and project. Whether implementing Good Laboratory Practices (GLP) standards, adhering to FDA guidelines, or aligning with emerging regulatory frameworks in India, the firm ensures that every analysis meets the highest accuracy, precision, and robustness standards.

From the outset, the company fosters open dialogue and collaboration, seeking to understand the precise goals, constraints, and aspirations of its clients. Project timelines, deliverables, and milestones are meticulously outlined, with transparent communication as the cornerstone of every engagement. Whether it’s method development, validation studies, or customized synthesis of impurities, RMS Scientific Services operates as a trusted ally dedicated to delivering actionable insights and tangible results.

Precision, Accuracy, & Robustness

Precision, accuracy, and robustness are non-negotiable virtues in the realm of analytical sciences. RMS Scientific Services leaves no stone unturned in upholding these principles, employing rigorous validation protocols, instrument calibration, and method optimization to ensure the reliability and reproducibility of its results. From assay validations with a margin of error as low as 0.2 percent for product release to accommodating a slightly broader tolerance of two percent for R&D projects, the company calibrates its processes to the unique requirements of each endeavor.

When it comes to precision, RMS Scientific Services ensures that method conditions are meticulously aligned. However, the degree of precision is tailored to each client’s specific needs. Some clients may opt for streamlined methods and validation parameters, foregoing extensive precision requirements. Nevertheless, to uphold reliability, the firm maintains instrument calibration and alignment to uphold precision, accuracy, and robustness standards. Precision, being of paramount importance, is meticulously ensured through replicate analyses. Whether it’s a single day’s work or an ongoing project, routine replication validates precision adherence.

Robustness, which pertains to a method’s resilience to minor environmental variations, is another focal point. RMS Scientific Services takes measures to mitigate the impact of such variations on results, particularly for well-established processes. Even amidst the diverse array of daily projects, this commitment remains unwavering. For projects spanning longer durations, clients may request strict adherence to particular parameters. In such cases, it diligently executes these specifications. Accuracy, contingent on the project type, such as formulation or placebo studies, is rigorously upheld by regulatory guidelines.

Despite its relatively young presence in the market, RMS Scientific Services has swiftly garnered recognition for its innovative approach to analytical challenges. Beyond traditional analytical services, the company has embarked on ventures such as customized synthesis of impurities, leveraging its expertise to deliver bespoke solutions that address the unique needs of its clients. Embracing the ethos of ‘slow, standard, and operational,’ the company continues to push the boundaries of analytical excellence, guided by a relentless pursuit of scientific innovation and customer satisfaction. Bolstered by a track record of success and a steadfast commitment to excellence, the company can play an instrumental role in shaping the future of India’s pharmaceutical landscape. With a focus on continual improvement, innovation, and unwavering dedication to quality, RMS Scientific Services can lead the charge toward a brighter, more resilient future for the pharmaceutical industry.