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 a real challenge.
The best approach to the above problems is the acquisition of external regulatory services, in other words - outsourcing.
What is „Regulatory outsourcing”?
Regulatory outsourcing in the case of SciencePharma 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;
- Interactions with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (in Polish: Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, URPLWMiPB), other governmental or regulatory authorities in connection with any product;
- Marketing authorization application (MAA) submissions;
- Life-cycle management: post-approval submissions (eg. variations, notifications, line-extensions, renewals), keeping track of annual fees, sunset clause exemption submissions;
- Regulatory dossier compilation (eCTD), publishing and dispatch;
- Updates and translations of product information (PI) in Polish and English;
- Translation of deficiency letters, MA and any other official documents into English.
- Review of the product mockups for compliance with PL and EU legislation.
Our experts can partner with you throughout the entire regulatory process and help you achieve all your goals.
Why should you use our experience?
We have experts with diverse and vast experience in the field of Regulatory Affairs in each of the registration procedures, but, most importantly, they all know the local requirements in Poland and have extensive experience in contacts with the Polish Agency.
For many years, our Regulatory Outsourcing has been used by many pharmaceutical companies with a diversified portfolio. Moreover, we successfully take care of products of the new pharmaceutical companies dissatisfied with previous RA consulting services, which undoubtedly proves the high quality of services provided by SciencePharma.
We serve clients from all over the world, helping them both in the registration of medicinal products in Poland and in all activities related to the maintenance of marketing authorization and to comply with the obligations imposed by law on the marketing authorization holders.
If you are interested in building a business relationship with us, please do not hesitate to get in touch with us! Our team of experts will address any questions or doubts you may have. Be in touch soon!