Contract Research Organizations offer services that include professional handling of chemicals. Ensuring standardized analytical services is the need of the hour in the present market as big companies in pharmaceutical and food industries outsource projects. They expect additional analytics that would help them find answers to longterm issues. This is the major challenge the clients face both in the domestic and international market. The base of CRO is their infrastructures which are equipped with synthesis and analytical laboratories. Lack of sophisticated infrastructure is the underlying limitation in CRO industry.
Analytica Chemie is one unique establishment of Chromachemie Group of Companies. It is a worldclass organization that has pushed through the challenges in CRO market and is one of the first companies to start a laboratory exclusively for the synthesis of pharmaceutical impurities and reference standards in India. The company established in Karnataka, India has managed to expand its operations globally. In words of the company MD, Ajey S. Rao, “We have synthesized and supplied more than 8000 impurities standards in our laboratory and maintain a stock of most of the commonly required impurities.”
The company operates in a very structured manner where it is able to handle the entire process systematically from receiving queries to dispatching of the product. The company holds clients in three different sectors namely, pharmaceutical, food and analytical testing industry. According to most efficient Mr. Rao, there have been changes in the demands of the clients. The clients now look for quality reference standards along with additional analytical data and support to support the regulatory compliances. Therefore, the organization is equipped with a division consisting of doctorates with vast experience apart from the strong synthesis and analytical team.
The company also has a separate division that consists of Computational chemistry and molecular modelling experts wherein sophisticated computational chemistry tools are used to simulate most efficient routes for synthesis for complex molecules and usage of most appropriate reagents which assure a very high rate of success and significantly shorten the time taken to synthesize the new molecule. Mr. Rao adds, “As our analytical laboratory is well equipped with sophisticated analytical instruments and is ISO 17025:2017 accredited, we offer analytical services like NMR and LCMS services to all the clients who require such services.”
The company operations are not limited to the above but also involve services of isolation and characterization of unknown impurities that are seen in the drug products. This is a distinguished feature of Analytica Chemie that adds to the competitive advantage of the company. “The company has a track record of delivering successful results in about 95% cases of delivering the results in the various complex projects on custom syntheses and process development of impurities, reference standards, metabolites, labelled compounds etc.” mentions Mr. Rao. The customer centric approach of the company has led to this success rate. Besides, the workforce in Analytica Chemie ensures that the services are delivered in timebound manner.
Analytica Chemie has put its main focus on the route of synthesis and method of analysis that has made the difference in their brand image and services. Their products are ISO certified and their GLP laboratories are ISO 9001:2015 certified. Such high capability helps the company integrate their functions with international businesses and reputed institutions. Mr. Rao says, “As India is considered the pharmacy of the world, Analytica Chemie takes the responsibility to cater the various standards to different parts of the world based on the specifications mentioned in their respective pharmacopoeia.” The company is eager to set benchmarks on reference standard qualities and impurity standards to make them globally acceptable.