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Meet our offer

RESEARCH AND DEVELOPMENT

We offer consulting services in the field of assessing the potential of various projects development of  medicinal products, devices or dietary supplements.

Audits

Having broad experience in auditing of API manufacturers as well as of contract medicinal products facilities we offer independent GMP auditing services.

PRECLINICAL AND CLINICAL DEVELOPMENT

SciencePharma is a leading, highly experienced consultancy company providing state-of-the-art services in a field of nonclinical and clinical studies.

PHARMACOVIGILANCE

Pharmacovigilance is the process of monitoring the safety of medicines. Marketing Authorization Holders have a legal obligation to set up and maintain a Pharmacovigilance system.

REGULATORY AFFAIRS SERVICES

We offer multidisciplinary services in the field of Regulatory Affairs including support for pre-registration, registration and post-registration.

SciencePharma Our achievements

20

R&D projects for medicinal products

231

comments on the possibility of product registration

523

documentation for medicinal products

397

No of medicinal products in our PhV system
News
the latest information

Variation - how to successfully update your dossier

13.06.2022
Have you been granted the Marketing Authorisation (MA) for your medicinal product? Are you about to release it into the market? That is for sure very positive information! Do you think it is over and from now on, nothing more has to be done? Unfortunately not. During your product’s life cycle you will surely deal with many improvements and face multiple post-approval variations to the quality dossier of your product. To assure the highest quality of your product you have to keep up with scientific progress and technical development, which may often lead to quality-related changes. ...

Borderline products: drug or device? Line of demarcation drawn by new MDCG guidance

31.05.2022
Medical device regulation 2017/745 (MDR) entered into full application on May 26, 2021, but still a lot of uncertainty is associated with its implementation. So far, over 70 guidance documents ...

Clinical Evaluation Report - grounds for clinical evaluation of medical devices

25.05.2022
Clinical Evaluation Report (CER) constitutes a significant part of technical documentation (TD) that summarizes and draws conclusions on the clinical evaluation of the medical device (MD). The ...