Qualiminds: Bringing Distinct Consulting Services with Simplicity and Value addition in Pharmaceutical Industry
Strategic transformation is at the core of life science companies as they build new business models for the future. Qualiminds, headquartered in Mumbai, is a distinct and unique Consulting company which offers comprehensive pharma services that match the services available from US and Europe qualitatively at affordable cost. Qualiminds' mission is to be an institute of repute to assist in strengthening Indian Pharma Industry in the area of GMP compliance and significantly improve country's credibility with international regulatory agencies as well as international customers on quality of drug products exported from India.
"We were concerned by the adverse inspectional observations by Regulatory agencies like US FDA, EMEA, WHO Geneva in the last 5-7 years and industry needed to build a good quality culture. Spate of Warning letters, Import alerts received by several companies in India and the need to assist needy companies to undertake remedial actions at affordable cost as compared to prohibitively expensive US/European Consultants inspired us to get into this space", said K Anand, CEO and Managing Director, Qualiminds.
Unique Services for Pharma Industry
Qualiminds is able to support entire range of manufacturing operations in pharma space in terms of Intermediates, Active Pharmaceutical Ingredients (APIs), all kinds of Dosage manufacturing facilities including Sterile drug products, and Biologicals.
Currently, several Pharma companies in India are facing Regulatory challenges due to serious deficiencies related to cGMP compliance, data integrity, poor QMS implementation, poor documentation management and training deficiencies at work place. Qualiminds additionally has capability to provide services in R&D and Project management for APIs and Finished dosages which is a distinct differentiator from other Consulting organizations.
"We were concerned by the adverse inspectional observations by Regulatory agencies like US FDA, EMEA, WHO Geneva in the last 5-7 years and industry needed to build a good quality culture. Spate of Warning letters, Import alerts received by several companies in India and the need to assist needy companies to undertake remedial actions at affordable cost as compared to prohibitively expensive US/European Consultants inspired us to get into this space", said K Anand, CEO and Managing Director, Qualiminds.
Unique Services for Pharma Industry
Qualiminds is able to support entire range of manufacturing operations in pharma space in terms of Intermediates, Active Pharmaceutical Ingredients (APIs), all kinds of Dosage manufacturing facilities including Sterile drug products, and Biologicals.
Currently, several Pharma companies in India are facing Regulatory challenges due to serious deficiencies related to cGMP compliance, data integrity, poor QMS implementation, poor documentation management and training deficiencies at work place. Qualiminds additionally has capability to provide services in R&D and Project management for APIs and Finished dosages which is a distinct differentiator from other Consulting organizations.
Qualiminds has excellent track record of successfully executing assigned tasks for their clients in a time bound manner. Some of the success stories for Qualiminds have been -
• Remediation at Svizera Lab leading to re-approval of site by WHO Geneva and EU after receiving Notice of Suspension (NoS) by WHO-Geneva,
• Successful US FDA approval of Neutraceutical facility of EID Parry
• Support to ZCL Chemicals in GMP approval by US FDA and EU
• Remediation of cGMP deficiencies at Raptakos & Brett for PICs certification
• Due Diligence of API and Finished Dosage facilities proposed for acquisition
• Building EU standard cGMP at Morison Pharma, in Sri Lanka
• And many more India with UK NHRI agencies for inspection.
Qualiminds is trying to assist few companies in Bio-logics space and also in to medical devices. The company has now tied up with an International pharma company in undertaking Due Diligence and subsequent upgradation of Quality systems at a medium size Oncology manufacturing facility in India, and also a Generic/Branded formulation manufacturing facility in Egypt.
• Remediation at Svizera Lab leading to re-approval of site by WHO Geneva and EU after receiving Notice of Suspension (NoS) by WHO-Geneva,
• Successful US FDA approval of Neutraceutical facility of EID Parry
• Support to ZCL Chemicals in GMP approval by US FDA and EU
• Remediation of cGMP deficiencies at Raptakos & Brett for PICs certification
• Due Diligence of API and Finished Dosage facilities proposed for acquisition
• Building EU standard cGMP at Morison Pharma, in Sri Lanka
• And many more India with UK NHRI agencies for inspection.
Qualiminds' mission is to be an institute of repute to assist in strengthening Indian Pharma Industry in the area of GMP compliance
Qualiminds is trying to assist few companies in Bio-logics space and also in to medical devices. The company has now tied up with an International pharma company in undertaking Due Diligence and subsequent upgradation of Quality systems at a medium size Oncology manufacturing facility in India, and also a Generic/Branded formulation manufacturing facility in Egypt.
