Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Zamann Pharma Support offers consultancy services, specializing in conducting thorough assessments to evaluate the current state of Process Validation within client organizations. Our focus is on identifying potential GAPs in the existing practices and assessing their compliance with international standards (e.g.: FDA and EMA)
We conduct a detailed review of the client’s existing Process Validation documentation, including validation protocols, reports, and related records. Our team evaluates the completeness, accuracy, and compliance of the documentation with regulatory requirements and industry best practices.
Zamann assesses the client’s Process Validation procedures and practices, including planning, execution, and reporting. We analyze the effectiveness and adequacy of the client’s validation methodologies, risk assessment processes, and acceptance criteria to identify any areas for improvement or enhancement.
We evaluate the client’s Process Validation activities against relevant regulatory guidelines and requirements issued by authorities such as the FDA and EMA.
Our team ensures that the client’s process validation practices align with current regulatory expectations and industry standards, identifying any non-compliance issues and providing recommendations for corrective actions.
We provide Qualification and Validation support, designed specifically to your facility and products, ensuring that each process is meticulously designed, documented, and verified. With our hands-on support, you can trust that your operations meet all regulatory standards
Zamann’s expertise in Qualification and Validation is rooted in industry best practices and rigorous global regulatory insight. Our team brings a thorough approach that secures compliance, improves reliability, and supports your facility’s operational success
