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Nitrosamines
The MAH is responsible for the quality, safety and efficacy of its finished medicinal products. This includes a risk assessment for the possible formation of N-nitrosamines. We support you in the preparation of your risk assessment [more information]
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Reclassification of ethanol and its consequences
A reclassification of ethanol as a CMR substance would lead to a ban on its use in the medical sector and as a biocidal active substance. [more information]
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Online Seminar on revised ERA Guidance
4 & 5 November 2025. Booking now available, more information
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PFAS: next steps
RAC and SEAC are continuing to look into the possible restriction of PFAS in certain product groups. The consultation on medical devices is due to take place in June 2025. [more information]
ACA-pharma concept GmbH Regulatory & Scientific Expert Services
We are a professional consulting company specialized in supporting you in your efforts to develop effective and safe products by providing expert services of highest quality. Gained by the Leadership Team, ACA-pharma concept GmbH is based upon wide experience within the pharmaceutical and consulting industries as well as academia. In close collaboration with highly experienced partners, ACA-pharma concept GmbH can accompany your projects from the first step through to its successful completion.
As required, we establish bespoke teams with the optimal composition and subject matter expertise to fully achieve client objectives. This guarantees flexibility, accuracy, consistency and high quality, and also allows to adapt easily to your special requests. Supporting pharmaceutical and biotech companies, in particular start-ups in developing effective and safe medicinal products by providing preclinical and clinical expert services of highest quality is a core competence of ACA-pharma concept GmbH.
