Regulatory Discovery & Compliance Alignment
Assessing client needs to ensure strict alignment with GxP, FDA, and other regulatory frameworks, while complying with 21 CFR Part 11.
Augmenticus has been a trusted partner for global enterprises in life sciences, pharmaceuticals, and BioTech. We provide cutting-edge solutions, from GxP compliance and Veeva CRM integration to AI-driven insights and Agile project management. Our services ensure regulatory adherence and operational excellence, empowering businesses to innovate and thrive in a competitive market.
Specializing in GxP compliance, FDA guidelines, and 21 CFR Part 11 for life sciences, Pharma, and BioTech industries.
From consulting to implementation, we support our clients through every phase of their projects.
Assessing client needs to ensure strict alignment with GxP, FDA, and other regulatory frameworks, while complying with 21 CFR Part 11.
Seamless integration of enterprise systems like Veeva CRM and Salesforce to optimize data management and ensure regulatory compliance.
Implementing AI-driven insights to reduce time-to-market, optimize decision-making, and drive operational efficiency across regulated sectors.
Leveraging Agile methodologies to deliver flexibility, rapid delivery, and continuous feedback loops, ensuring successful project outcomes.
Proactively managing risks and ensuring adherence to regulatory standards across the entire project lifecycle, mitigating disruptions.
Using Lean Six Sigma methodologies to optimize workflows, reduce inefficiencies, and enhance operational performance.
Managing the entire product lifecycle from concept through market introduction and post-market surveillance, ensuring compliance and success.
Ensuring ongoing communication between stakeholders, keeping projects aligned with business and regulatory goals.
Promoting sustainable solutions and innovative approaches, ensuring regulatory compliance while reducing environmental impact.
Equipping teams with the skills and knowledge they need to manage and sustain systems post-implementation.
Providing real-time tracking of project performance and regular reporting to ensure transparency and success.
Offering globally scalable solutions while ensuring localization to meet specific regional regulatory needs and market conditions.
Specialized in GxP, 21 CFR Part 11, and FDA compliance, ensuring adherence to global regulations.
Extensive experience in life sciences, pharma, and biotech, focusing on drug development and compliance.
Leveraging AI and machine learning to enhance operational efficiency and data-driven decision-making.
Efficient project management with Agile and Lean Six Sigma, ensuring continuous improvement.
Providing scalable solutions while ensuring compliance with regional regulatory requirements worldwide.
Committed to eco-friendly technologies and driving innovation to meet future demands.
Trusted by industry leaders like Johnson & Johnson, Novartis, Merck, and more for delivering complex solutions.
Utilizing the latest advancements in AI, cloud computing, and automation to drive efficiency and innovation.
Working closely with clients to tailor solutions that meet their specific business and regulatory needs.