Regulatory Services
Our Regulatory affairs department plays a key role from drug development to commercialization.
Regulatory Affairs experts are involved in all phases of development, and even after drug approval and commercialization. They possess a unique combination of both scientific and management skills to achieve a commercially important goal within a drug development organization.
The Regulatory Affairs department provides strategic and technical advice at the highest level in such companies. In this way, they make a significant contribution, both commercially and scientifically, to the success of a development program and the company as a whole.
Our RA team members are with specific expertise to ensure that products are developed, manufactured, and controlled at all levels of expected quality, safety, and efficacy.
As a discipline, regulatory affairs (RA) covers a broad range of specific skills and occupations. Under the best of circumstances, it is composed of a group of people who act as a liaison between the potentially conflicting worlds of government, industry, and consumers to help make sure that marketed products are safe and effective when used as advertised. People who work in regulatory affairs negotiate the interaction between the regulators (the government), the regulated (industry), and the market (consumers) to get good products to the market and to keep them there while preventing bad products from being sold.
Some of the responsibilities of the regulatory department are the following:
- Study and interpret the rules
- Constantly check the legislation and monitor any updates
- Ensure the registration and compliance of products on the market with the legislation of the territory
- Evaluate product registrability in countries of distribution
- Prepare and update technical dossiers and product regulatory documentation
- Prepare registration documents and carry out all the necessary actions to complete the registration of products abroad
- Mediate between authority needs and company needs
- Revise artworks and promotional materials from a regulatory point of view.
As it can be imagined, the regulatory department is essential in the creation process of a new product, since it allows to understand the characteristics that the product can have, and the process needed to be able to have the product on the market in the shortest possible time, being in contact with all company departments to allow the registration of the product on the market and the distribution of the product. The role of the regulatory is equally fundamental during the whole life cycle of the product when it is important to analyze variations that are needed on the products and their dossier and to implement the needed activities in order to allow the compliance of the product following changes of the normative. Thus, the RA department has multiple responsibilities and areas of expertise and is a connection point between different company dimensions. Its role is in constant transformation and has a much more dynamic nature than one might think at first.