We provide consulting activities in different areas of the pharmaceutical industry, applying strategies and solutions adapted to each case.
Oxygen Care Ltd. may provide consultancies in various projects for Regulatory Affairs activities in the pharmaceutical industry – from initial submission of a product to more complex management of compliance issues and post-registration activities.
Our services can be requested separately, covering only parts of projects in progress, or we can offer you comprehensive services in the regulatory affairs area.
Switching from a prescription to OTC products is taken into consideration, for more and more drugs products manufacturers. Achieving such stage requires knowledge and practical experience with OTC regulations. Oxygen Care can help you either by switching of medicines subject to prescription to OTC products or to develop and register OTC products.
Generics
Whether you own a portfolio of generics or older molecules that have a well-established use, Oxygen Care Ltd may generate all the regulatory documentation necessary and can go through the evaluation and approval process to bring the product to market. No matter what type of application you intend to apply for, National, Mutual Recognition, Decentralized, Centralized, generally bibliographical, hybrid procedure – we can offer strategic advice to choose the best solution.
Food supplements
Oxygen Care Ltd. offers services for obtaining the authorization (notification) for food supplements, from the Ministry of Health or the Institute of Food and Bioresources.
Medical devices
Oxygen Care Ltd. offers consulting and registration services of medical devices. Our consultants have experience in all areas of the field, and can offer its expertise in registration of class I, II or III medical devices.
Oxygen Care Ltd. offers services and advice to manufacturers and external dealers to promote pharmaceutical products on the Eastern Europe markets, including the Romanian market.