regulatory affairs
Regulatory Affairs personnel are responsible for preparation and maintenance of product registration dossiers in all markets where Douglas Pharmaceuticals is currently active or intends to be.
The registration division incorporates specialized regulatory expertise by having teams specifically responsible for registration in: Africa, Australasia, Asia, Europe, Middle East, North America, and South America. These teams work closely together to ensure that while their thinking is global, local requirements are not neglected. Their expertise also provides considerable back-up support for the rest of the company.
Douglas products and/or developments are currently registered or awaiting registration in the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Cambodia, Czech Republic, Columbia, Denmark, El Salvador, Finland, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay and Venezuela.
To support product registrations applied for and/or granted specifically in the name of Douglas, the Regulatory Affairs Division also arranges investigation and submission of both patent and trademark applications. In the latter instance, the company owns a portfolio of over 210 trademarks for which registration has been applied for or approved.
With harmonisation of product dossier formats, and incorporation of the International Committee on Harmonisation (ICH) guidelines for pharmaceutical development, export partners can have confidence in the quality of Douglas products.
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