Welcome to Laboratory
We are Itrace Pharmaceutical Solutions Private Limited founded on September 26, 2020. Company is established by the likeminded experts in the field of analytical chemistry.
Itrace Pharmaceutical Solutions is fully equipped with the latest technology and is ready to satisfy your needs and demands. Knowledge, experience, and commitment of our team ensure that we provide value-added results and solutions to our clients.
Our Team
Our team of professionals has over 30 years of experience in the pharmaceutical industry.
Our team is made up of scientists, chemists, and other professionals who have worked together for years on various projects. Our goal is to provide the best possible service to you at all times by understanding your business needs and providing solutions that fit your budget while meeting all regulatory requirements.
We are experts at developing new analytical methods and troubleshooting existing ones to ensure your product is analyzed accurately, quickly, and efficiently. Our experience in analytical research, Trace level analysis, investigation, regulatory and troubleshooting makes us a preferred choice for your needs.
Also, we provide solutions for your needs of nitrosamine testing and tailor-made extractables and leachable studies.
Our experienced team is capable to provide the support and assistance to solve your most complex and challenging analytical challenges. Our team has a long history of providing analytical services to clients in the pharmaceutical, chemical, and food industries.
Dr. Atul Nalavade
Dr. Atul Nalavade
Senior Director- Operations
Dr. Atul has a strong interest in analytical method development for E&L studies as well as trace level analysis. He has overall experience of 20 years in analytical research field with various reputed organisations. Atul is involved in study design, analysis planning and consultation of extractables and leachables studies. He has guided for more than 500 studies on various dosage forms, process components and medical devices. He obtained his PhD in Chemistry from Gitam University with an emphasis on genotoxic impurities method development and validation in various drug molecules with Mass spectrometer. Prior to Itrace he has worked with GVS Cibatech, Intertek, Macleods pharma and Ranbaxy research laboratories in analytical research divisions.
Mr. Sachin Vandare
Mr. Sachin Vandare
Director (Marketing and Sales)
Sachin has overall experience of 13 years in analytical and customer facing role. He has experience of working with leading Pharmaceutical companies and CROs. He has led the Extractable and Leachable, Nitrosamine and other method development and validation as well as stability, elemental analysis activities. He has led project planning, technical discussions and customer co-ordination for successful execution of projects. He has successfully faced USFDA and multiple audits by leading pharma companies. He has completed his Master’s Degree in Analytical Chemistry. Sachin has started his carrier with Maceleods pharma. He has also worked with Glenmark and USV pharmaceuticals in analytical divisions. Prior to Itrace he has worked with Intertek, Analytical Solutions at managerial levels.
Mr. Sushil Davande
Mr. Sushil Davande
Director (Laboratory Operations)
Sushil has overall experience of 15 years in the analytical research field. Since last Eight years his major focus is on execution of E&L studies for various packaging systems and processing components for drug products as well as E&L studies for medical devices. Sushil has very good experience in Analytical method development and validation for N-Nitrosamine impurities, Genotoxic impurities, Residual Solvents by GC, Related Substances and Assay by HPLC. Sushil has Master’s degree in Chemistry from Mumbai University. Prior to Itrace he has worked with GVS Cibatech and Intertek as laboratory in-charge. He has also worked with Macleods pharmaceuticals and Watson Pharma in analytical research divisions.
Mr. Saurabh Chaudhari
Mr. Saurabh Chaudhari
Director (Laboratory Operations)
Saurabh has overall experience of 13 years in the analytical research field. Since last Nine years Saurabh led the E&L and Trace analysis laboratory activities which included laboratory operations, procurement, project planning and training of subordinates. Saurabh has vast experience in Analytical method development and validations of N-Nitrosamines, Genotoxic impurities and leachables in various dosage forms. Saurabh has completed his Master degree in Chemistry from Mumbai University. He has started his career with Watson pharma in analytical development department, also worked with Macleods pharma and Aarti Industries. Before Itrace, he has worked with GVS Cibatech, Intertek at managerial levels.
Mr. Vivek Nalawade
Mr. Vivek Nalawade
Director (Quality and Compliance)
Vivek has overall experience of 16 years in Quality field. He has successfully established the GLP compliant quality systems also carried out internal audits and successfully faced multiple audits by leading pharma companies. He was also the key member of the team in the USFDA audits in different pharma companies. He has experience of working in Analytical development and validation. Vivek has completed his Master’s degree in Chemistry from Mumbai University. Before joining Itrace, Vivek has worked with GVS Cibatech Pvt. Ltd., Polypeptide laboratories Pvt. Ltd., Watson pharma Ltd. and Macleods Laboratories Ltd. in Quality and Analytical field
Mrs. Neha Wandare
Mrs. Neha Wandare
Director (Quality and Compliance)
Neha has overall 10 years of experience in analytical research and quality field. She has led the compliance team in leading analytical CRO. She has successfully faced various customer audits, regulatory inspections also carried out internal self-inspection audits. She has been instrumental in on-time solutions and closure of QMS documents. She has also participated in regulatory inspections (e.g. Local FDA, USFDA). She was responsible for delivering internal trainings. She was responsible for assisting with customer and product queries and complaints and product investigations. Neha has completed Master’s Degree in Analytical chemistry from Mumbai University. She has worked with Analytical Solutions and USV limited prior to joining Itrace team.
Quality Policy
Facility Overview
iTrace Pharmaceutical Solutions private limited is registered in Sep-2020. Laboratory is set up in around 2800 sq. ft. space equipped with all the necessary well maintained analytical instruments.