Dr. Raman Nanduri

CEO

In the pharmaceutical sector, the industry is revolving around heightened demand for advanced analytical methods development and validation services. Stringent regulatory requirements and the constant pursuit of quality, safety, and efficacy in drug manufacturing fuel this surge. Pharmaceutical companies are increasingly relying on contract laboratories to navigate these regulatory landscapes efficiently. Such labs not only ensure compliance but also gain a competitive edge by offering swift, accurate, and reliable analytical testing solutions. However, customers do encounter various challenges, such as navigating regulatory complexities, ensuring product quality and safety, managing rising material costs, and balancing cost-effectiveness with visually striking designs. Analys Lab is a rapidly expanding contract analytical testing laboratory in India, specializing in cGMP/cGLP-compliant services for the pharmaceutical industry. With cutting-edge facilities in Hyderabad and Vishakhapatnam, the company upholds international standards of quality and ensures precision and adherence to industry regulations, offering customized testing solutions tailored to meet the client's needs.

Precision Testing for Pharmaceutical Success

Founded on a vision to provide swift, accurate, and meticulous analytical testing solutions to the global pharmaceutical industry, Analys Lab embarked on its journey with a commitment to excellence. From its inception, the company faced various challenges inherent in the pharmaceutical sector, including stringent regulatory requirements, escalating material costs, and the continuous pursuit of quality, safety, and efficacy in drug manufacturing. However, the team at Analys Lab remained undeterred, leveraging their expertise and dedication to overcome these obstacles. One of the significant challenges encountered by the firm was establishing itself as a trusted and reliable partner in the competitive landscape of contract analytical testing laboratories.

Building brand recognition and establishing credibility in the market required strategic decision-making, exceptional quality standards, and personalized services tailored to meet the specific needs of clients. Despite these challenges, the company has positioned itself as one of the fastest-growing cGMP/cGLP contract analytical testing laboratories in India, setting international standards for quality and excellence. The company's success can be attributed to its customer-first approach, where client needs and preferences are prioritized in every aspect of the decision-making process. “Analys Lab stands as a trusted partner for the global pharmaceutical industry, contributing to the success and growth of its clients through comprehensive testing solutions and unwavering dedication to quality”, says Dr. Raman Nanduri, CEO, Analys Lab.

Analys Lab offers a comprehensive suite of services in the pharmaceutical sector, encompassing analytical method development and validation, analytical testing, and microbiology testing for non-sterile products. It recognizes the pivotal role of refined analytical methods in drug development programs and provides tailored solutions built on extensive experience and expertise. The company’s method development, optimization, and modification services adhere to international cGMP standards, ensuring alignment with regulatory requirements.

In the realm of analytical testing, Analys Lab offers protocols covering quality control tests, pharmacopeial studies, solid-state drug characterization, trace metal analyses, and more. The company prioritizes accuracy, safety, efficacy, and stability in its testing procedures, utilizing advanced technologies and industry-standard protocols. Furthermore, Analys Lab excels in microbiology testing services for non-sterile products. Equipped with cGMP and cGLP-compliant facilities, the company conducts comprehensive testing, including environmental monitoring, microbial limit tests, bacterial endotoxin tests, disinfectant validations, bacterial identification tests, and various physical and chemical parameter assessments for pharmaceutical water. “The commitment to delivering precise and reliable testing services, coupled with cutting-edge facilities and strict adherence to protocols, positions Analys Lab as a trusted partner for pharmaceutical companies seeking to maintain safety, excellence, and regulatory compliance in its operations”, says Dr. Raman Nanduri.

Pioneering Analytical Excellence

Analys Lab stands out in the competitive realm of contract analytical testing laboratories through a confluence of distinctive factors. The company not only recognizes the evolving landscape of the pharmaceutical sector but deems analytical method development and validation not as trends but as imperative necessities. Anchored in ongoing research and development, it leads in providing reliable assays ahead of the market, catering to the specific timelines required by its generic clients. The company diligently adheres to regulatory standards, utilizing a system-driven quality management system, ensuring data integrity through ALCOA+ principles, and employing LIMS for seamless processes from sample registration to report generation. Handling deviations and out-of-specification results with precision, Analys Lab follows comprehensive procedures, aligning with FDA and MHRA guidance.

The team at the company, consisting of highly qualified professionals, including doctorate and post-graduate scientists, researchers, and experts in various fields, ensures that every analysis is conducted with precision and adherence to industry standards. The qualifications and training programs for laboratory personnel, covering induction, initial, functional, and practical aspects, showcase the commitment to expertise and compliance. With qualified analytical equipment, preventive maintenance, and calibration procedures, the company ensures reliability and accuracy in analytical data, maintaining compliance with 21 CFR Part 11. Additionally, the company's approach to sample handling and storage, along with a dedicated focus on future innovation through a specialized research and development group, positions Analys Lab as a trailblazer in this industry.

Analys Lab envisions a future roadmap marked by the establishment of a dedicated research and development group. This strategic initiative aims to keenly address the unique needs of innovator clients, fostering close communication and providing regular updates on method development crucial for emerging drugs. With a commitment to creating ‘The Standard in Analytical Research’ from a Contract Research Organization (CRO) perspective, Analys Lab is poised to elevate its capabilities and set new benchmarks in the dynamic landscape of analytical research.