Estima Pharma Solutions-Abetting Pharmaceutical Industry with GxP Consulting
Life Sciences faces major hurdles such as the increasing pressure of regulatory bodies, boom of generic products and the augmented stress on R&D departments to deliver more. Thus the industry needs a competent and effective approach to ensure compliance to reduce time to market, distinguish its products, including associated costs with competitors. Based in Bangalore, Estima Pharma assists pharmaceutical companies to meet International Standards within committed timelines and achieve GMP (Good Manufacturing Practice) compliant quality management systems. The organization ventures to deliver confidentiality and competitiveness to foster long term partnerships with clients. “We are established to provide pharma solutions worldwide along with a wide range of services primarily in the areas of pharmaceutical development & GxP Consulting and identify quality system requirements for GMP compliance”, says Dr. Gurudatta G.G, CEO & Director, Estima.The challenge to the pharmaceutical industry is to develop quality systems, compatible with GxP principles that not only formally cover quality but also ensure good scientific and technical performance. Being a GxP consultant, Estima Pharma provides solutions that offer extended services to BABE (Bio-Availability and Bio-Equivalence) and clinical monitoring including outsourcing of API as well as contract manufacturing location outsourcing. Moreover, Estima aids regulatory agencies like MHRA, TGA, MCC, AFSSAPS in preparation and submission of audit compliance reports. Additionally, Estima renders On-site training courses for GMP and system auditing for establishment of Quality Management Systems as per international regulatory guidelines.
The company offers complete support for qualification & validation of facilities, equipment, utilities as well as analytical method validations. Furthermore, Estima’s service ranges from reviewing and upgrading the quality management systems to comprehensive oversight of vendors, systems, manpower & regulatory certification.
Association with Nuwill
Working with its subsidiary company Nuwill Research and Innovations (P) Ltd., Estima assists pharmaceutical companies with its back office support for product development dossiers and Intellectual Property Rights. “While associating closely with our clients such as Claris Life Sciences, Taiguk Pharma, Korea SCD Pharma Korea and Phil Inter-Pharma Vietnam to name a few, we have successfully cleared 36 international regulatory audits”, adds Dr. Guradatta.
Apart from clearing audits, Estima is recognized for Commitment to Quality, Leadership, Technology and Innovation. The organisation has received the Century International Quality ERA Award for compliance on QC 100 TQM (Total Quality Management) Model criteria in 2015 from Business Initiative Directions (BID) Spain. While operating in adherence to the regulatory requirements, Estima Pharma is aggressively expanding its expertise to regions such as South Korea, South Africa, China, Vietnam, South East Asia and the African continent. Striving to provide cost effective & quality services within defined timelines, Estima intends to become an acclaimed GxP group for total pharma business solutions.
Association with Nuwill
Working with its subsidiary company Nuwill Research and Innovations (P) Ltd., Estima assists pharmaceutical companies with its back office support for product development dossiers and Intellectual Property Rights. “While associating closely with our clients such as Claris Life Sciences, Taiguk Pharma, Korea SCD Pharma Korea and Phil Inter-Pharma Vietnam to name a few, we have successfully cleared 36 international regulatory audits”, adds Dr. Guradatta.
Estima aids regulatory agencies like MHRA, TGA, MCC, AFSSAPS in preparation and submission of audit compliance reports
Apart from clearing audits, Estima is recognized for Commitment to Quality, Leadership, Technology and Innovation. The organisation has received the Century International Quality ERA Award for compliance on QC 100 TQM (Total Quality Management) Model criteria in 2015 from Business Initiative Directions (BID) Spain. While operating in adherence to the regulatory requirements, Estima Pharma is aggressively expanding its expertise to regions such as South Korea, South Africa, China, Vietnam, South East Asia and the African continent. Striving to provide cost effective & quality services within defined timelines, Estima intends to become an acclaimed GxP group for total pharma business solutions.
