Innovative Research and Synthesis Facility :
Our cutting-edge research and synthesis facility stand as a testament to our unwavering commitment to research and innovation. This facility serves as the crucible where novel ideas and groundbreaking solutions are forged into reality. It is the birthplace of pioneering pharmaceutical products and solutions that push the boundaries of science and technology.
Environmentally Responsible Process Development:
At Cerata Pharmaceuticals LLP, we recognize the importance of environmental sustainability. Our Process Development and Support Centers, located in both of our manufacturing units, are dedicated to the development of environmentally friendly processes. These processes are designed not only to meet high-quality standards but also to minimize our environmental footprint. We prioritize efficiency and eco-consciousness in all our endeavors.
Comprehensive Process Development and Scale-up:
Our Process Development Centers are at the forefront of process innovation. Starting from gram-scale experiments, we meticulously guide processes through various stages of development. This includes process optimization, impurity profile analysis, pilot studies, pre-validation batches, and the validation of processes. We leave no stone unturned in ensuring that our processes are robust, reliable, and ready for scale-up.
Process Support Centers:
The Process Support Centers at Cerata Pharmaceuticals LLP play a pivotal role in our commitment to quality and regulatory compliance. These centers diligently review and improve processes, providing invaluable insights that help our Quality Assurance team during investigations. They are also instrumental in assisting our regulatory team in addressing queries from regulatory bodies. Their expertise ensures that our processes not only meet but exceed the highest industry standards.
Quality Control
At Cerata Pharmaceuticals LLP, we firmly believe that quality is not just a promise but a genuine performance that speaks volumes about our dedication. Quality control is at the heart of our operations, and we spare no effort to ensure that our products meet and exceed the highest industry standards.
Advanced Quality Control Facilities:
Our Quality Control testing and validation labs are equipped with cutting-edge analytical equipment and state-of- the-art testing facilities. These facilities are essential in our commitment to delivering products of unparalleled quality.
Comprehensive Quality Control:
Our highly skilled Quality Control Team is engaged in a wide range of critical tasks, including the routine analysis of raw materials, in-process samples, intermediates, final/finished APIs, water quality, packing materials, end-of-run cleaning samples, and environmental monitoring of bio burdens in API pharmaceutical areas. Their meticulous work is integral to maintaining the integrity and safety of our pharmaceutical products.
In-House Analytical Instruments:
Cerata’s commitment to quality control extends to our in-house capabilities. We have invested in a comprehensive array of analytical instruments, including UPLC, HPLC, GC, Particle Size analyzers, XRPD, LC-MS, GC-MS, stability chambers, moisture analyzers, and all necessary microbiology equipment. This comprehensive instrumentation ensures that our quality control processes are efficient and reliable, and we are not dependent on outsourcing for testing.
Our dedication to quality control is not just a commitment; it's a way of life at Cerata Pharmaceuticals LLP. We take immense pride in our in-house capabilities, which enable us to maintain rigorous control over the quality of our products from start to finish. Our mission is to deliver pharmaceuticals that not only meet but consistently exceed the expectations of our customers, regulators, and partners. Quality isn't just a word; it's the cornerstone of everything we do.
Quality Assurance
Cerata's Quality Assurance and Regulatory Affairs teams maintain vigilant oversight of our Quality Management System. Our unwavering commitment to upholding the highest standards in cGMP manufacturing is evident through regular system reviews and continuous improvement efforts. Notably, both our manufacturing units have successfully passed more than 30 rigorous cGMP audits conducted by diverse regulatory authorities. Additionally, we've welcomed over 2000 quality audits from our valued customers, embracing their feedback to enhance our operations continually. Cerata's dedication to quality assurance is deeply embedded in our ethos, ensuring our products consistently meet stringent safety and efficacy standards.