New Members

Asphalion is an international scientific and regulatory consulting company with more than 25 years of experience supporting the life sciences industry. We provide strategic, regulatory, scientific, and compliance services to pharmaceutical, biotechnology, ATMP, veterinary, and medical device companies throughout the entire product lifecycle — from early development to post-marketing. Our expertise includes regulatory strategy and submissions (EMA and global markets), clinical and CMC support, pharmacovigilance, regulatory intelligence, lifecycle management, and compliance. We help companies obtain and maintain marketing authorisations while ensuring alignment with evolving European and international regulations. Asphalion operates under certified quality and information security management systems (ISO 9001 and ISO 27001), ensuring high standards of quality, reliability, and data protection. Asphalion MedTech, our specialised medical device division, supports manufacturers of medical devices and IVDs with MDR/IVDR compliance, CE marking, clinical and performance evaluation, post-market surveillance, and technical documentation. A key pillar of our support is the implementation, optimisation, and maintenance of ISO 13485-compliant quality management systems, ensuring robust regulatory compliance, efficient processes, successful Notified Body interactions, and long-term market sustainability under the MDR/IVDR framework. We are strongly committed to digitalisation and innovation in regulatory science, actively exploring digital tools and AI-driven solutions to optimise regulatory processes, enhance data analysis, and support compliance. We are particularly interested in the regulatory framework surrounding AI, digital health, and data governance in the EU. As members of EUROPHARM SMC, we look forward to actively contributing to working groups, sharing regulatory expertise, engaging in industry discussions, building partnerships, and participating in events, while supporting members in their regulatory and digital transformation challenges.

With over 50 years of experience in the research and development, registration, manufacturing and marketing of medicinal products the German pharmaceutical industry association BPI represents the whole range of the pharmaceutical industry at national and international levels. Some 250 companies with 70000 staff have joined forces in our association. The BPI membership stretches from pharmacies selling medicinal products under their own name to multinational companies with worldwide distribution networks. For all of them the BPI is an ideal information and communicationplatform. The BPI aims to further develop health care in a future-oriented way, inter alia by intensively participating in the reform discussion in the health sector. To ensure that patients receive the medical products and therapies they need, the BPI flights to preserve the large variety of hirgh-quality drugs in all therapeutic fields-adhering to our motto "life is variety". For this purpose the BPI is engaged in a constant dialogue with other health care partners and the general public. To meet requirements of our time, the BPI is for member companies both a lobbyist and a service provider.

-

Crimson Ridge Partners is a healthcare deal advisory firm focused on creating value through high-impact transactions across sectors, including pharmaceuticals, biologics, medical devices and digital health. We support owners, founders and management teams with mergers and acquisitions, licensing and strategic partnerships, enabling healthcare companies — from emerging innovators to established regional leaders — to achieve their strategic objectives through well-structured, sustainable and repeatable transactions. As an end-to-end transaction partner across the full value chain, we integrate deal advisory with R&D, regulatory, legal, commercial and supply chain considerations to ensure that transactions are not only strategically sound, but also practical, executable, and sustainable. We originate and execute transactions involving: - Innovators seeking funding and collaborations for clinical development and geographical expansion; - Regional healthcare SMEs aiming to strengthen their product portfolios and commercial reach; - CDMOs and manufacturers pursuing commercial partnerships to access a broad scope of markets; - Healthcare service providers including hospitals, CROs, laboratories and diagnostics platforms; - Digital health companies transforming access, patient experience and outcomes. Crimson Ridge Partners is built by and for healthcare deal makers. Our partners have held senior leadership roles in global biopharmaceutical and healthcare organizations, and bring more than 50 years of experience across developed and emerging markets, working with companies at different stages of maturity, scale and lifecycle. We are not generalist advisers; we are focused solely on healthcare. In a complex and rapidly evolving industry, Crimson Ridge Partners delivers clarity, momentum, and results when transactions matter most.

Owlpharma is a Portuguese consultancy providing services to the pharmaceutical and healthcare products industries. We present a highly qualified and multidisciplinary team, with know-how and expertise in Regulatory Affairs, Pharmacovigilance, Quality Assurance, Medical & Scientific Affairs, Audits and Medical Devices, covering the complete lifecycle of health and medicinal products.

Founded in 1969, Tecnifar is a family owned, Portuguese Pharmaceutical Company. Operating in Portugal and former Portuguese colonies, Tecnifar sells its own off-patent (non generic) pharmaceutical forms and also commercialises under license, patented medicines from major R&D companies, such as MSD, AstraZeneca, UCB, J. Uriach and Angelini. TECNIFAR is incorporated in TECNIFAR GROUP which also comprises WELANCE (OTCs, medical devices and food supplements) and IMAG (imagiology clinics). Research is an inherent commitment for Tecnifar, who firmly believes that it should contribute to the advancement of medical science through the R&D of new innovative products, and is currently expecting IND approval for it´s medicinal product based on bacteriophage therapy. TECNIFAR GROUP is currently searching for OUT and IN licensing opportunities for medicinal products, medical devices and food supplements.