REGULATORY OUTSOURCING

• Regulatory dossier compilation, publishing and dispatch
• Updates and translations of product information
• Review of the product mockups

Obtaining a new marketing authorization, compliance with the regulatory requirements throughout the whole product life cycle, which consists of a large number of various types of procedures (eg. renewals, post-registration variations, notifications) and obligations related to the payment of annual fees or informing about the marketing status of the product requires a considerable amount of work. Therefore, solving local regulatory problems and monitoring ongoing regulatory changes is à real challenge.
The best approach to the above problems is the acquisition of external regulatory services, in other words - outsourcing

Regulatory outsourcing in the case of Hub Net Scientific Pharma is a broad concept that covers many activities that our experts perform for our clients in the field of Regulatory Affairs. Undoubtedly, if your company has or intends to have products registered in Poland in their portfolio - local requirements may surprise you. Depending on the needs of your company, our cooperation may cover the range of activities that suits you.
Our services include among others:
Full regulatory service and consultations concerning actual normative regulations referring to registration, renewal, variations and notifications of medicinal products;