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Regulatory Affairs

54 employees

Expertise in eCTD file preparation for GCC- Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates (UAE). CTD Compilation, ACTD Compilation, Medical Devices, Cosmetics, Personal care, Supplements, Veterinary, and Herbal products with authorities throughout the Globe. We are Contract Research Organization (CRO) that provides integrated services and consultancy to Pharmaceuticals, Biotechnology, Nutraceuticals, Herbal, Cosmetics and Medical devices companies. Regulatory professionals are responsible for: Keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products. Advising on legal and scientific restraints and requirements. Collecting, collating and evaluating scientific data. Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing. authorization for the products concerned. Giving strategic and technical advice at the highest level in their companies, making an important contribution both commercially and scientifically to the success of a development program and the company as a whole Helping the company avoid problems caused by badly kept records, inappropriate scientific thinking, or poor presentation of data.

Basic info

Industry

Pharmaceutical Manufacturing

Sectors

Pharmaceutical Manufacturing

Date founded

2009

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