Jacqueline Audenaert-Simonse

Regulatory Affairs at Regulatory Affairs - Gurugram, Haryana, India

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Regulatory Affairs

Gurugram, Haryana, India • 130 Employees
Pharmaceuticals

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 .authorisation 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 programme and the company as a wholeHelping the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data.

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