Design, Construction & Qualification of Facilities

PTS Global Pharmaceutical Consulting assists our clients to ensure their facilities, equipment and processes function at an optimum level through our commissioning and qualification services. Our commissioning and qualification team has the experience and technical skills to ensure our clients’ facilities meet or exceed their expectations. We are able to quickly identify needs and solutions and will work with the clients’ team to complete the project within their budgets, boundaries and expectations.

PTS Consulting will develop commissioning documents to document and verify proper installation; optimum operation at start-up; functional performance; turnover of facilities, systems and equipment.

TURNKEY SYSTEMS:

Financial pressures, market competition, regulatory challenges and time-to-market issues require innovative, flexible solutions for a successful project.

PTS Global Services has a proven approach to custom designed, compliant cleanrooms. By combining the right architectural solution with the best engineering expertise, we can deliver a cleanroom that will meet specific business objectives and provide confidence throughout the business life-cycle

COMMISSIONING SERVICES :

  • Develop and execute commissioning plans supportting the project schedule
  • Provide commissioning documents (e.g., User Requirement Specification, inspection forms, Factory Acceptance Tests and Site Acceptance Tests)
  • Inspect for physical completion
  • Audit Vendors
  • Witness vendor commissioning activities
  • Manage commissioning activities of owners, vendors, construction contractors and contract resources
    Execute commissioning activities for utility and process equipment systems
    Maximize opportunities for leveraging with qualification activities

QUALIFICATION SERVICES :

  • Verification & Validation
  • Process Validation
  • CleaningValidation
  • Environmental Qulifications (Air, Water, Soil)
  • ASTM E2500
  • Installation Qualifications

Pharamacutical Consulting

DEVELOPMENT

NDs (Investigational New Drug) & ANDs (Abbreviated New Drugs)

APPLICATION

Filing & Managing all of the Processes for FDA Drug Applications

COMPLIANCE

FDA and Global Regulatory Compliance and Submission

MANUFACTURING

Complete Facilities Design from inception to full FDA qualification

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