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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

The quality data of medicinal products in the registration dossier

19.01.2022
Module 3 is a part of the Common Technical Document (CTD) that contains all  the quality data needed to the registration of a human medicinal product. The CTD is a special documentation format used for the submission of registration information of medicinal products to regulatory authorities. In 2003, it became required for all medicinal product submissions in the EU, Japan and recommended in US. It is worth noting that more and more other countries also adjust to this format, for example Switzerland, Turkey, Brazil, Singapore, Canada, Republic of Korea, China or Chinese ...

Medical Device Regulation – Regulatory aspects

23.11.2021
You've probably heard that after years of discussion, the European Medical Devices Regulation has been reviewed and was adopted on May 2017. Therefore the safety, quality and performance ...

OTC status – what is it all about?

09.11.2021
In general, medicinal products can be bought on prescription or over the counter (OTC). Many products introduced on prescription in the past, now are freely available without it. If you have in ...