Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Our service is dedicated to overseeing and coordinating Nitrosamines ICH M7 adaption projects for pharmaceutical companies. We ensure meticulous planning, execution, and monitoring of every project aspect to guarantee compliance with regulatory standards and timely completion.
Detailed planning of project activities, milestones, and timelines to align with regulatory requirements and client expectations.
Development of comprehensive project schedules to track progress and ensure adherence to deadlines for each phase of the adaptation process.
Facilitation of effective communication and collaboration among project stakeholders, including regulatory affairs, quality assurance, R&D, and manufacturing teams.
Regular meetings and updates to keep stakeholders informed about project progress, key milestones, and any issues or challenges encountered.
Identification and assessment of potential risks and issues that may impact project timelines or compliance objectives.
Implementation of proactive risk mitigation strategies and timely resolution of issues to minimize disruptions and maintain project momentum.
Our strategic approach to ensure Nitrosamine compliance is based on global and holistic experience, and can be perfectly adapted to your reality. We address the latest regulations and risk assessments, helping you manage and mitigate potential risks specific to your products and processes.
Zamann stays ahead of the evolving Nitrosamine requirements, providing expert guidance to ensure compliance with confidence. Our proactive and senior approach helps protect product integrity and patient safety, securing your operations against regulatory risks.
