Regulatory Affairs Management for the Pharmaceutical Industry

products-servicesMericon AS
April 18th 2013

Mericon AS is an independent Contract Research Organisation (CRO) with long experience and knowledge in Regulatory Affairs Management for the pharmaceutical industry.

Our team of Regulatory Affairs Professionals is highly skilled in the complex and ever changing regulations and guidelines and is able offer assistance at all levels. We offer services for the entire life cycle of products, from preparation of marketing authorisation dossier to maintenance of the marketing authorisation. Our expertise covers medicinal products for human and veterinary use, as well as herbal medicinal products. We also assist in regulatory/marketing work related to medical device, functional food and cosmetics.

Mericon AS provides the following services:
• Guidance according to the very latest national/European procedures and requirements.
• Assistance in ensuring that law, regulations and guidelines for marketing of medicinal products are observed.
• Preparation of high quality Norwegian translations of relevant documents.
• Assistance in direct contact with the Norwegian Medicines Agency (NoMA).
• Preparation and maintenance of product information in The Norwegian Pharmaceutical Product Compendium (Felleskatalogen).

For more information or to discuss Regulatory Affairs Management please contact Mericon AS directly.