MakroCare is a leading provider of specialized solutions and services to Pharma, Medical Device and Biotech firms, announced today that it is certified with ISO/IEC 20000-1:2005 certification.
Achieving ISO 20000 along with previously obtained certifications ISO 9001 and ISO 27001 will enable MakroCare support global clients and their projects with standardized QMS foundation by following information security standards backed by consistent service management.
Mahesh Malneedi, president of the company mentioned “We are the first in race with this rare TRIPLE ISO certification combination for companies providing clinical, regulatory, informatics, commercialization, and management consulting services. These certifications will help us provide consistent quality with predictable delivery on all projects of our customers”
MakroCare is an international drug development and commercialization services firm that is dedicated to efficient high-level performance in combination with unparalleled client satisfaction supporting from offices in USA, Europe and Asia. MakroCare has 5 subsidiaries/divisions – Consulting, CRO, SMO, DDi and Commercialization. MakroCare has teams positioned worldwide in these divisions supporting product life cycle management, regulatory affairs, risk management, regulatory compliance, trial management (clinical, late phase), monitoring, biometrics (CDM, EDC, Biostat, SAS programming), Medical Writing (Regulatory, Clinical), QA audits, Drug safety / Pharmacovigilance, Site management, Patient Recruitment, Informatics (EDC, CTMS, IVRS), Commercialization, and Marketing/Sales.