serving the pharmaceutical & related industries

Pharmaceutical Consulting

Development

Pharmaceutical Development

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

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Application

Pharmaceutical Application Processing

Filing and Managing all of the Processes for FDA Drug Applications

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Compliance

Pharmaceutical Compliance

FDA and Global Regulatory Compliance and Submission

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Manufacturing

Pharmaceutical Manufacturing

Complete Facilities Design from inception to full FDA qualification

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Design, Construction and 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. design-consruction-commisioning-pharmaceutical-facilities

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
Contact PTS Global Services