About us
Kamakshi Kalyani Akkana is a Managing Director of QSPECTRA, and was instrumental in setting up the activities like Training, Audits and building QSPECTRA team.
Kalyani has 8 years of experience in the pharmaceutical industry, having worked with major pharmaceutical companies like Biocon and Aurobindo.
Kalyani holds a masters in Biotechnology from Madras University.
Patrudu is having 22 years of professional experience in the pharmaceutical industry in top pharma industries, where he covered roles related to the management of Production and Operations, as well as Quality. Throughout his career he developed a strong background in successfully managing internal and external audit processes. Before QSPECTRA, Patrudu was Manager – Quality Assurance in Hetero Corporate, Hyderabad.
Patrudu holds a MSc in Organic Chemistry from Osmania University and Diploma in Total Quality Management form AIIMS, Chennai.
Krishna is a professional chemist, having 18 years of experience in the pharmaceutical industry, where he covered roles related to the Quality Control and Regulatory Affairs. Throughout his career he developed and addressed many regulatory queries, DMFs and having a strong background in Regulatory Affairs.
Vamsi holds a MSc in Organic Chemistry from Osmania University.
Our Company
–> Started in March 2015.
–> Quality and Regulatory consultancy services for compliance to USFDA, EDQM, EU GMP, MHRA, TGA, PMDA, MCC,
KOREAN FDA, COFEPRIS, HEALTH CANADA and other regulatory agencies for API and FORMULATIONS.
–> Assisting pharmaceutical companies in upgrading Quality Management System, Facilities, Regulatory
submissions and Inspection.
–> Guide in the preparation and / or review of Regulatory Submissions – DMFs, EDMFs. CEP Dossiers.
–> We assist in DMF deficiencies, reply to 483 observations (USFDA) and audit observations of other regulatory
bodies through a team of qualified and experienced Quality & Regulatory professionals.
–> Third Party Audits for API / Intermediate and Formulations facilities as per ICH Q7 GMP guidelines, EU GMP
guidelines.
Address
Hyderabad, Telangana, 500072.
Call Us
+91 89782 51234
Email Us
patrudu@qspectra.in