The regulatory committee’s regulatory business can help you explore the shortest path and time to market your products and support them throughout their life cycle. The regulatory committee Regulatory Affairs team provides comprehensive regulatory support from pre-clinical to commercialization. The Regulatory Affairs Consultants New York come up with the best results for the same now.
At the pre-registration stage, they support your requests for scientific advice, they prepare and review the research kits for experimental drugs, the investigator brochures (IB) and they assist you in defining the appropriate submission regulatory strategy. The service includes advice on reviewing and submitting informed consents for many types of products:
- orphan drugs
- biological drugs
- biotechnology products and innovative therapies
- biosimilar products
- generic drugs
New chemical substances
With strong expertise in preparing and reviewing clinical trial submissions, regulatory committee guides you through your applications in Europe, Canada, the United States, using the database and regulatory expertise (procedures and procedures).
If you plan to market your product in Europe, regulatory committee will work closely with your team, develop a customized regulatory strategy for your product (portfolio) and guide you through procedural obstacles and all interactions with health authorities. They support all procedures (mutual recognition, decentralized and centralized) with preparation, review and submission of your business license applications.
After registration, regulatory committee regulatory affairs will contribute to the maintenance and life-cycle management of your products related to changes, extension of lines, renewals, submission of Periodic Safety Update Reports and responses to requests made to the authorities.
The position of Regulatory Affairs Manager is a key function within a pharmaceutical or medical device manufacturer.
The Regulatory Affairs Manager works closely with other departments in the company, including research and development, marketing and quality.
What are the missions of the Regulatory Affairs Manager?
The Regulatory Affairs Manager is responsible for a product portfolio. It is his responsibility to define and implement a regulatory strategy on this portfolio. He brings his contribution and his expertise to the negotiation of the conditions of the placing on the market of the products, so that this one is done in the best conditions and as soon as possible.
The Regulatory Affairs Manager implements an effective strategy to ensure that the products placed on the market are fully compliant with the regulations in force. He is in charge of studying and evaluating the possible regulatory impacts of a modification on a product (formula, packaging)
The Regulatory Affairs Manager is the contact for the regulatory authorities and is responsible for responding to any requests from them.
What is the path of a regulatory affairs manager?
To become a Regulatory Affairs Manager, it is often required to have a pharmacist degree.In addition, to become responsible for the regulatory affairs of an international pharmaceutical company, you must have 8 to 10 years of experience in regulatory affairs. Management experience is also required. After several years in the position, the head of regulatory affairs can claim positions of high responsibility within the research and development department of the Pharmaceutical Laboratory.