Contact Us today to find out more information about our Manufacturing Services!
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FDA, EPA, and SEC Manufacturing Compliance

CastleHill Managed Services provides the people, tools, automation and process management required to successfully navigate the technical, legal and corporate requirements, regulations and practices manufacturers must comply with in order to produce and market products. Our comprehensive end-to-end approach provides any regulated manufacturing organization with an instant capability to establish and maintain an effective control and compliance assessment environment. CastleHill solutions can be efficiently and effectively applied to pharmaceutical manufacturers, medical device manufacturers, biotech companies, biologics developers and contact research organizations, as well as other subset of manufacturing industries.

CastleHill Managed Services, platforms and processes are compatible with numerous standards and compliance domains including:

ISO 9001 Health, Safety, and Environmental Impact
ISO 13845 Data Protection
IEC 61215 Export Controls
IEC 61646 Anti-Corruption
Good Manufacturing Practices (GMP) IT Safety and Security
Conflict Minerals Fair Competition
Product Safety Employment Law

Ask us how CastleHill can help you build and maintain an effective and
cost efficient Manufacturing Compliance capability!

End-to-end delivery of people, process and technology

CastleHill Managed Risk Solutions, provides critical services and expert guidance to companies operating in highly regulated environments. We accomplish this through managed risk assessment, advisory and support services, application of best practice, end-to-end traceability and the provisioning of high quality actionable data.

    Enjoy Measurable and Observable ROI
    Reduce costs while realizing immediate improvements in enterprise Governance, Risk and Compliance maturity
    Reduce impact on managers and operational staff
    Focus on risk mitigation, core competencies, capital preservation and revenue generation
    Automate and consolidate risk management activities while simultaneously eliminating real and perceived conflicts of interest, process gaps and technology shortcomings
    Eliminate time-consuming administrative support functions that lead to blurred roles, organizational inertia, functional bias, incomplete data and poor data quality
    Leverage our dedicated teams of professionals, encouraging SME functional continuity while eliminating single points of failure
    Clients enjoy improved risk management effectiveness without incurring additional technology support burden or cost

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Information Management is built into every solution we provide

Nothing to plug in or purchase. CastleHill provisions and maintains the industry leading tools that facilitate your success!

Incorporating this system in conjunction with our Managed Services provides a wide range of aggregate capability including:

  • Assessment Management
  • Document Management
  • Issue Management
  • Regulatory, Policy and Procedure Management
  • Controls and Control Testing Management
  • Advanced Dashboards, Reporting and Analytics
  • Advanced Notification and Communications
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CastleHill delivers expert capability, tailored to your organizations specific needs

We know our customers like our clients know theirs. Partnering for the long term means client success is our success.

Our experienced professionals provide all of the guidance and expertise necessary to ensure successful setup and delivery of our promised end state.

Single Tenant Platforms

We use what our clients use. All platform instances are single tenant and all clients work with a dedicated full coverage team leveraging the same environment.

Fast Access

Dedicated full coverage teams mean fast access to process and platform changes, custom reports and metrics, solid lines of communication and strong feedback.