Our Regulatory Affairs Consultancy is dedicated to serving the pharmaceutical industry. We’re always improving and developing our service and our many results.
Respect the confidentiality of restricted information with which we’re entrusted.
Declare any conflict of interest that we know to exist that will affect the performance of our work.
Understanding your business by our good knowledge is that the functions of regulatory affairs play a major role in the growth of investment.
Dealing with all types of registration dossiers (Innovators, Brands, generic, Health, cosmetics, Medical devices and food) from multiple resources.
Our growth and success come from our commitment, credibility, transparency and clarity with our clients.
Manage (GMP License) activities such as audits, regulatory agency inspections, or product recalls for Middle East & Gulf Authorities.
Manage (GMP License) activities such as audits, regulatory agency inspections, or product recalls for Middle East & Gulf Authorities.
Manage (GMP License) activities such as audits, regulatory agency inspections, or product recalls for Middle East & Gulf Authorities.
Lead submission and response activities (planning, preparation, review, coordination, submission) as key Middle East & Gulf Authorities contact.
Prepare reviewing report for dossier and work with company regulatory team to cover all missing document to ensure regulatory compliance by creating awareness of requirements ....
Reviewing the dossiers (Technically & Administrative data) according to updated required guidelines Saudi Food and Drug Authority (Middle East) & Council for the Arab States of the Gulf (Gulf Authorities) to reduce time of registration.