Get full R&D, medical and scientific support

Comprehensive Support in Medical, Scientific, and Product Argumentation for the Polish and European Life Sciences Markets – Expertise in R&D for Pharmaceuticals, Medical Devices, and Dietary Supplements

We offer specialized support in preparing robust, scientifically grounded medical, product, and scientific arguments tailored for the Polish market, with extensive experience in navigating the complex regulatory landscape of the broader European Union. Our expertise includes advanced formulation development of pharmaceutical products, with a particular focus on borderline products—those exhibiting characteristics of both medicinal products and foodstuffs, including dietary supplements. Accurate classification and regulatory compliance of such borderline products are critical, requiring in-depth knowledge of EU pharmaceutical legislation (Directive 2001/83/EC), medical device regulations (MDR 2017/745), and food law (Regulation (EC) No 1924/2006 on nutrition and health claims).

We conduct thorough scientific and market research (Scientific & Market Due Diligence) to identify optimal product positioning and commercialization strategies, leveraging insights from pharmacokinetics, pharmacodynamics, toxicology, and molecular biology. Our team is proficient in performing risk-benefit assessments aligned with EMA guidelines and supports the preparation of dossiers for regulatory submissions, including Marketing Authorization Applications (MAA) and Technical Documentation for medical devices.

Additionally, we offer tailored training programs to enhance your team’s competencies in Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and the latest European regulatory requirements governing pharmaceuticals, medical devices, and dietary supplements. Our scientific expertise spans multiple therapeutic indications and cutting-edge methodologies such as PCR, next-generation sequencing (NGS), and proteomics, enabling us to deliver comprehensive evaluations of product safety, efficacy, and quality.

We facilitate contract manufacturing negotiations (with Contract Manufacturing Organizations – CMOs) and represent your interests throughout technology transfer processes, manufacturing scale-up, and Quality Risk Management (QRM) assessments, ensuring compliance with ISO 13485 and ICH Q7 guidelines.

Partner with us to develop high-quality, scientifically accurate, and regulatory-compliant Polish-language marketing and educational content for the life sciences, pharmaceutical, and medical sectors. Our Medical Writing and Scientific Writing services encompass regulatory documentation, clinical study reports, and marketing materials designed to communicate complex scientific data effectively to healthcare professionals and regulatory authorities.

If you require expert support in preparing medical, scientific, or marketing texts in Polish or for the broader European market, we are at your disposal. Our team is deeply familiar with life sciences terminology, medical nomenclature, and EU regulatory frameworks, including the EU Food Supplements Directive (2002/46/EC) and the European Pharmacopoeia standards. We support you throughout the entire product lifecycle—from preclinical and clinical development phases, through regulatory approval, to successful market entry and ongoing pharmacovigilance.