Preparation of documents for marketing authorization
Our team takes the responsibility of preparation of documents for marketing authorization of a new or existing product (extensions of marketing authorization). With long experience in the field of pharmaceutical development our team ensures that your documents are processed in a highly competent manner.
Our services in this field include preparation of:
- Application for marketing authorization according to Notice to applicants and Common Technical Document (CTD) standard.
- Preparation of EU Drug Master File
- Preparation of pharmacological and toxicological expert’s reports
- Preparation of clinical expert’s report
- Literature research in all relevant data banks
The market for health food is growing enormously and the regulatory aspects in this field is quite complex. We help you through the regulatory guidelines of health claims and to prepare the application to establish health claims of your food supplements and novel foods.
For product promotion rely upon our expertise and experience. Following are the examples of marketing literatures that can help you to promote your product:
- An experts review of your product in relation to bioactive substances and their pharmacological properties
- Preparation of a handbook for therapeutics
- Preparation of brochure, flyer and other product promotion literatures