Business and regulatory services

Introducing a new product to regulated markets requires not only advanced technology but, above all, proficiency in constantly evolving legal regulations. The consulting services sector at PCI Days is a place where pharmaceutical, cosmetic, and dietary supplement manufacturers find support in regulatory affairs processes, certification, and operational optimization. This allows for safe and rapid business scaling while maintaining full compliance with regulatory requirements.

Regulatory Affairs and Product Registration

Ensuring regulatory compliance is the foundation of legal security for every manufacturing facility. Specialized support in this area includes:

Marketing Authorization for Medicines and Supplements: Comprehensive preparation of registration documentation (CTD/eCTD) for medicinal products and notifications to the Chief Sanitary Inspectorate (GIS) for dietary supplements.
Safety Assessment and Cosmetic Documentation: Preparation of Cosmetic Product Safety Reports in accordance with Regulation 1223/2009 and full management of the CPNP portal.
Audits and Implementation of Quality Systems: Preparing plants for GMP (Good Manufacturing Practice), ISO 22716, and HACCP certification, as well as conducting audits of raw material suppliers.

Research, Certification, and Financing of Innovation

A modern product must be supported by scientific evidence and a stable financing model:

In vivo, in vitro, and clinical testing: Commissioning tests to confirm the claimed efficacy of active ingredients, as well as stability and packaging compatibility testing.
Intellectual Property and Patent Protection: Advice on trademark, industrial design, and patent protection for innovative formulations and technologies.
Financing and Grants: Support in obtaining funding for research and development (R&D) projects and the modernization of machinery for automation and eco-design.

Consulting Services – Strategy and Operational Optimization

Modern industry requires efficient management at the process and environmental levels:

Technology Transfer and Cost Optimization: Consulting on the transfer of production to contract manufacturers (CDMOs) and cost audits of recipes.
PPWR Compliance and ESG Reporting: Environmental audits to help align packaging and the supply chain with EU sustainability requirements.
Product Liability Insurance: Specialized policies protecting manufacturers against the consequences of potential defects in products introduced to international markets.

Table: Key areas of regulatory support and certification

Industry	Main regulatory issues	Certification/notification required
Pharmacy	Serialization, Drug Master File (DMF), GMP.	URPL, GIF, EMA (drug registration).
Csmetics	INCI, Safety Assessment, Clean Beauty.	CPNP portal, security reports.
Supplements	Novel Food, health claims.	GIS (notification), EFSA.

PCI Days provides a platform connecting knowledge providers with decision-makers, enabling direct consultations on resolving issues related to formulation stability, ingredient interactions, and complex marketing authorization procedures.

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Who is it for:

Producers and distributors of raw materials and components
Producers and distributors of machinery and equipment
Representatives of the packaging industry
Suppliers of laboratory equipment and technologies
Suppliers of logistics solutions
Suppliers of IT and technological solutions supporting production
Contract manufacturers of pharmaceuticals, cosmetics and dietary supplements, as well as private label service providers
Suppliers of services supporting the pharmaceutical, cosmetics and dietary supplement industries
Representatives of institutions, associations, universities and industry organizations

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