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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
Responsibilities of the Marketing Authorisation Holder (MAH) after obtaining the Marketing Authorisation (MA) for the medicinal product in Poland

Responsibilities of the Marketing Authorisation Holder (MAH) after obtaining the Marketing Authorisation (MA) for the medicinal product in Poland

01.03.2023
As soon as the MA has been granted for the medicinal product, the MAH is responsible for the product's quality, efficacy and safety. Therefore, the MAH is obliged to comply with national and European legislation. It is important to remember that depending on the country in which the medicinal product has obtained the MA, the MAH has different obligations, which must be kept in mind in order to fulfill them in a timely and diligent way. However, the topic of this article is the MAH's duties after obtaining the MA in Poland, and therefore we will mainly refer to the national ...
Clinical trials – where to conduct them?

Clinical trials – where to conduct them?

01.02.2023
Each drug developer at some point reaches the moment when it is necessary to run a clinical trial, and has to ask themselves  where to test the developed medicinal product. However, there is ...
Skin products - What’s new in the ICH Q3D Guideline For Elemental Impurities?

Skin products - What’s new in the ICH Q3D Guideline For Elemental Impurities?

18.01.2023
Have you heard about the new version of the ICH Q3D Guideline for Elemental Impurities? Do you know, it was adopted on 24 March 2022 by The Committee for Medicinal Products for Human Use (CHMP) of ...