Areas of Expertise

Our services for medicinal products cover the entire lifecycle — from development and authorisation to market access and post-marketing compliance. Our team has extensive experience with a wide range of product types, including small molecules, radiopharmaceuticals, biologics, herbal medicines, vaccines, diagnostics, and combination products. This broad expertise enables us to deliver tailored, effective solutions for our Clients – whether the focus is on development, regulatory approval, or ongoing compliance.

Services:

• development strategy and consulting on quality, clinical, and non-clinical documentation
• management of marketing authorisation procedures (national, MRP, DCP, centralised)
• eCTD dossier compilation, gap analysis, and pre-submission alignment
• preparation and review of IMPD, SmPC, PIL, and labelling texts, mock-up checking
• preparation and submission of PSURs, DSURs, and RMPs
• pharmacovigilance system setup, including QPPV and LPPV provision
• EudraVigilance and ICSR management, xEVMPD data maintenance
• safety database management and global/local literature monitoring
• regulatory communication, audit readiness, and CAPA management
• SOP development, PSMF preparation and maintenance
• strategic consulting for market entry and lifecycle management

With our integrated approach, Clients can rely on us to ensure that their products meet all regulatory expectations while supporting business goals and accelerating time-to-market.

Ensuring the safety and compliance of medical devices requires continuous regulatory support throughout the entire product lifecycle.

Services:

• documentation and certification support for CE conformity
• preparation of technical documentation and clinical evaluation
• EUDAMED registration, post-market surveillance (PMS), and vigilance system management
• preparation of PSUR and SSCP
• audit preparation and communication with authorities

Bringing food supplements and FSMPs to market and maintaining compliance requires precise documentation and regulatory expertise.

Services:

• preparation and submission of notification documentation
• support in developing compliant labelling texts
• verification of health claims

Safe marketing of cosmetic products depends on regulatory compliance and sustained consumer trust.

Services:

• review of registration documentation and labelling texts
• compilation and maintenance of Product Information Files (PIF)
• safety assessments of ingredients and finished products
• implementation of cosmetovigilance systems
• monitoring and reporting of undesirable effects and trend analysis