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Investment Due Diligence

  • AuditingBuying a business highly complex, especially a business which produces pharmaceutical products. The last thing you want is to find out that significant quality or regulatory issues may be present after you close. AMICUS can perform quality and regulatory audits to identify GAPs which may pose a potential risk to the business. With all GAPs identified, you will be able to adequately assess the business risk and overall potential financial impact of the purchase.

FDA Preparedness Audit

  • A significant portion of how well you do in a regulatory audit is in how the audit is handled. AMICUS can perform audit simulations to identify potential compliance GAPs and assist you with developing a sound audit plan and process.

Production Efficiency/Enhancement

  • Sometimes the greatest opportunities can turn into the biggest problems. Every year businesses fail by drowning in opportunity. AMICUS consultants have direct industry experience with 503B scale up and we can assist you with turning your successful proof of concept into a larger scale operation. We assess your current production environment/processes and develop a plan that is consistent with the goals of your business.

Vendor/Supplier Auditing

  • Vendor/supplier qualification is and integral part of compliance in cGMP operations. It remains a common deficiency noted on a majority of 483 observations. AMICUS can assist by performing audits of vendors on your behalf, ensuring a robust qualification process free of the knowledge gaps that may be present in your operation.

Quality Systems should be developed in line with the overall goals of your organization to heighten quality and supply chain security. Utilization a quality systems solution that does focus on your organization strengths and weaknesses can create an environment in which quality and business success suffer. AMICUS utilizes a methodology which focuses on your business vision and ensures that quality systems are developed in a manner which is achievable and compliant.

  • NCR Investigation Program
  • Deviation Program
  • CAPA Program
  • Change Control Program
  • Customer Complaint Program
  • Adverse Drug Event Reporting Program
  • SOP Development
  • Facility Design and Enhancement
  • Materials, Process, and Personnel Flow
  • Batch Production Record Development
  • Calibration and Maintenance Program Development
  • Process & Product Development
    • Mixing Studies
    • Hold-Time Studies
    • Stability Program
  • Equipment Management
  • ValidationValidation Master Plan Development
  • Aseptic Process Validation Design & Execution (Media-Fills)
  • Process Validation Design & Execution
  • SIP Development & Qualification
  • CIP Development & Qualification
  • Temperature Mapping & Storage Qualification
  • Environmental Monitoring Performance Qualification
  • Auditing & Reporting
  • 483 Response Drafting Assistance
  • Warning Letter Response Drafting Assistance
  • Corrective Action Implementation, execution, & monitoring
  • Compliance Master Plan Development
  • Project Management

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