Regulatory Affairs

Drug and medical device registration is one of the services we offer to our partners. The extensive experience we possess in regulatory affairs is the result of our many years of registering and placing a large number of brands in the local markets with success.

Our drug registration service is based on our continuous monitoring of regulations, product life cycle tracking, exceptional familiarity with the regulatory processes and our long-standing close communication with regulatory institutions and agencies.

By closely monitoring the current legal regulations in this field, we are able to offer you a comprehensive solution encompassing the following activities, which precede the registration stage:

• Preparation of application dossier in CTD format
• Translation of necessary documentation and submission to the relevant institutions
• Proposed designs for outside and inside packaging
• Drafting of product summaries and packaging leaflets
• Following up on the registration process until the drug and medical device sales & marketing license is received
• Amendments of registration documents
• Renewal of registration
• Pharmacovigilance