PROFESSIONAL PHARMA SOLUTIONS

Always we are looking to offer a higher level of service and expertise with our perssonel
to the pharmaceutical, medical devices, and biotechnology industries.

WE ARE HIRING

JOIN OUR TEAM NOW
OUR SERVICES


About US

Our Experience Makes Us Unique And Means Quality

PPS is a Puerto Rican owned company that specializes in the areas of Regulatory Compliance Services and Validations, but offers services in other areas such as Documentation, Quality Control, Quality Assurance, Technology Transfer, Technical Service, Training, and Consent Decree Issues. PPS is looking to offer a higher level of service and expertise to the pharmaceutical, medical devices, and biotechnology industries. PPS is your partner in assuring an accurate, timely, well organized, and cost effective work.

The Company was conceived as one based on excellence in quality of service, a place where its employees could fully develop their talents and share in the financial success of the firm. Beyond regulatory compliance related issues, PPS strives to build business relations based on trust, honesty, integrity, and the quality of our work.

We bring the best associates with extensive experience in solving problems that our clients face in a daily basis. Our associates are chosen for their knowledge, commitment, experience, consulting, and management expertise.

Profile

The PPS's Experience

  • PPS has vast experience in FDA regulated industries in the areas of quality , validations, engineering, product transfer , manufacturing, laboratory, and compliance.

  • Developed guidelines for the Pharmaceutical Manufacture Company Reaction to a Consent Decree Emitted by the Federal Drug Administration (FDA).

  • Certified Biomedical Auditor and Certified Quality Auditor courses by ASQ (American Society for Quality).

  • Woman Own Small Business (WOSB) Certified.

  • Minority Business Enterprise (MBE) Certified.

  • HubZone Certification in progress.

  • PRMA Member (Asociaciónde Industrialesde PR)

Mission

Achieve a world class quality standards on the areas of Validation, Regulatory Compliance, and Technical Support derived from the knowledge, professionalism, and commitment of our team by offering an efficient, flexible, and cost effective approach to our clients

Vision

Become the best outsourcing company that provides their customer with talented professionals to help them meet their challenges and succeed in their organizations

Our Deluxe Services

Our Service is Personalized And Of High Quality

...

Packaging & Manufacturing Validation

  • Packaging Line Equipment and Process
  • Manufacturing Equipment and Processes
...

Lab Equipment Qualification/Test Method

    • HPLC, GC
    • UV-visible
    • IR
    • Spectrophotometers
    • Karl Fisher/li>
    • Ovens
    • Balances
    • pH meters
    • Incubators
...

Facilities and Utilities Validation

  • Production and Clean Room
  • HVAC / AHU
  • Compressed Air
...

Process Validation

  • Production and Clean Room
  • Characterization
  • IQ
  • OQ
  • PQ
  • Commissioning (FAT/SAT)
  • Decommissioning
...

Computer System Validation (CSV)

  • Production and Clean Room
  • Characterization
  • Part 11 Compliance
  • Validation PLans
  • Designs (HDS/SDS)
  • Mfg. Execution
  • Systems (MES)
  • LIMS
  • SAP
  • TRACKWISE

Consulting Expertise in Regulatory Compliance Services, Validation, Documentation, Engineering and Consent Decree Issues Providing Services to FDA Regulated Industries.



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