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Commitment to Quality

Ethicare is committed to uncompromising quality in all areas of our business. We conduct projects and activities efficiently and in accordance with international quality standards, best practices and ethical principles to ensure that our clients and regulatory authorities are provided the best possible services and products.

The Ethicare Quality Management System

To comply with international quality standards, best practices and ethical principles, Ethicare designed a Quality Management System. This system ensures that all operations and projects adhere to regulatory requirements and guidelines, such as:

  •  Schedule Y Guideline of Drug Controller (General) of India
  •  US 21 Code of Federal Regulation relevant sub parts
  •  EudraLex Volume 10 Clinical Trials guidelines
  •  ICH guidelines
  •  Other industry standards

The Ethicare Quality Management System consists of the following elements:

  •  Quality assurance
  •  Well structured organization with highly qualified personnel
  •  Detailed Standard Operating Procedures (SOPs) describing responsibilities and duties
  •  Regular audits
  •  System improvement and consultancy

The Ethicare Quality Assurance department

Our Quality Assurance (QA) department is an independent unit reporting to the Ethicare Senior Management. The department’s main focus is the continual improvement of Ethicare’s Quality Management System to ensure the required quality fulfillment.

Our clients regularly conduct audits of our well structured Quality Management System. We have successfully passed all external client audits. Ethicare conducts an Internal Audit Program in all areas of our business to maintain our reputation for quality and compliance.

Involved in every step of clinical development, Ethicare’s QA ensures that your projects will receive the highest level of quality and efficiency. System improvement is a continuous process at Ethicare. Our QA personnel maintain an optimal level of knowledge through ongoing continuing education and regular participation at QA and other conferences.