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Project Management and Strategic Planning 

Successful companies move forward to a common goal by clearly establishing a strategic plan and then acting towards this goal with well defined outcomes and timelines.  GXP farma can help design action plans and short and long term strategic plans to support your company's success.

Responding to Regulatory Agency Issues

 

Perhaps no goal is more important than being prepared for inspections by regulatory agencies. GXP farma offers programs to help prepare and host regulatory inspections.  As well, programs for how to quickly and concisely respond to any inspectional issues are also needed. Each program is customized to your particular resources and company needs. No "one size fits all" program really works.

Quality and Regulatory Strategic Programs 

 

Planning, planning , planning.  The best project can fail if there is no plan to support it.  GXP farma can help you develop a strategic plan aimed at creating a high quality and compliant organization from Day One.  Experience gained from many inspections by GXP frama staff has identified patterns of activities that have led to compliance issues and even company failures.  Knowing these in advance greatly helps you develop a custom plan for your successful implementation.  

 

GXP farma also offers training programs to support all levels of regulatory and quality activities usually found in the pharmaceutical industry.  Let GXP farma teach your staff, or train your trainers, so that your entire team knows how to move your projects forward!  

Quality and Regulatory Management System

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We offer technical and quality expertise, ensuring GXP compliant practices, supporting you in navigating the regulatory path for your product. Built upon years of FDA experience, our Quality Programs meet technical and regulatory requirements in a cost-efficient manner.

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  • Quality/Compliance strategic Plan

  • Quality Manual

  • Standard Operating Procedures (SOP’s)

  • Validation Master Plan

  • Sample management

  • Deviation management

  • Corrective Action, Preventative Action (CAPA) Programs

  • Change Control

  • Document Control

  • Maintaining IND Regulatory Compliance

  • Training management

  • Organizational roles and responsibilities

FDA+Approval+Pathways+Drugs+Biologics+Sm
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