Regulatory Compliance Management

Your partner in achieving and maintaining regulatory compliance

In today’s dynamic regulatory landscape, life sciences organizations face the constant challenge of adapting their compliance practices to meet evolving regulations and stringent anti-corruption laws. Ensuring regulatory adherence is critical for maintaining quality and safeguarding patient safety. At Navitas Life Sciences we offer a comprehensive suite of Regulatory Quality services designed to help you navigate these complexities with confidence.

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Ensuring quality and safety in every aspect of your operations, our services include:

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Our expert team provides robust compliance solutions to keep your operations aligned with global standards:

  • Corrective and Preventative Actions (CAPA) : Timely identification and resolution of deviations
  • Audit Readiness : Comprehensive assessments to prepare for internal, external, mock, and ISO audits
  • Auditing : Expert support for conducting internal, external, mock, and ISO audits
  • Quality Management System (QMS) : Detailed reporting and analysis to ensure regulatory compliance
  • Quality Risk Management : Thorough reviews to identify and mitigate risks
  • IT Systems Implementation : Providing end-to-end system validation with comprehensive documentation and support for new systems
  • Global Quality Compliance Monitoring : Ongoing oversight to ensure adherence to international quality standards
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Effective procedure management is vital for regulatory compliance. We offer tailored support to streamline your processes:

  • SOP Management : Timely review and management of global and local Standard Operating Procedures (SOPS) via pharmaREADY® DMS
  • Non-GxP Processes : Assistance in creating clear and effective working instructions
  • Records Management : Expertise in managing and maintaining critical regulatory records
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We understand the importance of continuous learning and adherence to Good Manufacturing Practice (GMP) standards:

  • GMP Documentation : Maintenance of comprehensive GMP documentation from onboarding to continuous development
  • Onboarding Programs : Development of customized onboarding programs with relevant training modules
  • Training Management : Efficient tracking and management of training activities via pharmaREADY® TRMS
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Our project management services are designed to enhance operational efficiency and compliance:

  • Lean Training Setup : Streamlined approach to organizing training activities
  • Technical Contributions : Expert input for project teams or sub-teams
  • Change Control Management : Effective change control via eQMS
  • Operational Excellence : Support for initiatives aimed at achieving operational excellence

CASE STUDY

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Delivering Quality Insights with qualityREADY® for a global pharma company

Learn how we worked with our client to implement qualityREADY®, our robust quality intelligence platform to provide deep insights into critical quality metrics enabling proactive decisions for improved quality outcomes.

BROCHURE

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qualityREADY® Analytics

Learn more about our robust Quality Intelligence platform providing actionable insights into critical quality metrics to improve operational efficiencies.

ARTICLE

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The Windsor Framework: Insights on the regulatory shift for medicines

Read our article as we explore the key regulatory implications of this framework and offer clarity on how businesses can efficiently navigate this transformation.

BLOGS

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How to provide ‘Outstanding’ Regulatory Compliance Services to a Top 10 Global Pharma

Learn more about our a leading global pharma company commended our support highlighting our collaborative approach and teamwork in the successful migration of regulatory files.
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Navitas Life Sciences’ Regulatory Labeling Services – Ensuring Compliance with the latest Regulations

Operating in a highly regulated industry, it is vital to comply with strict regulations and guidelines to ensure the safety and efficacy of products.
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Why Reliance Life Sciences has been using pharmaREADY® for over 10 years

As an established industry technology partner, our Fit-For-Purpose technology is enriched by our experience and insights as we enable organizations to do more with less.

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