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Member Benefits on Quality/Regulatory Services with PSC Biotech®

Member companies receive a 10% discount on PSC Biotech’s professional services, including quality, regulatory, validation, and project management support tailored to the life sciences. With global expertise and decades of experience, PSC Biotech® helps organizations meet compliance standards, streamline operations, and bring products to market faster.

Exclusive member benefits include support in:

Commissioning, Qualification & Validation (CQV):

  • CQV planning, documentation, and protocol execution

  • Validation Master Plans, IQ/OQ/PQ, and summary reporting

  • Facility, utility, and equipment qualification

  • Deviation resolution and change management

Computer System Validation & IT:

  • eQMS, ERP, and BMS system validation and integration

  • Data integrity gap assessments and audits

  • Serialization support for packaging regulations

Regulatory Affairs & Quality Assurance:

  • Regulatory strategy and submission management

  • Quality oversight, SOP development, CAPA support

  • Regulatory inspection remediation and documentation

Audits & Compliance:

  • Supplier, facility, lab, and safety audits

  • cGxP gap analysis and PAI preparation

Calibration & Engineering:

  • Field and lab instrument calibrations

  • Equipment commissioning and thermal mapping

  • Preventive maintenance and technical writing support

Project Management:

  • Fractional or full-time project management

  • Capital projects, CQV projects, and construction punchlist support

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Member benefits, exclusive discounts, and more.

 

 

About PSC Biotech®

PSC Biotech® is one of the world’s largest life sciences consulting firms, supporting more than 1,000 clients across 35+ countries.

Specializing in quality, validation, regulatory, and compliance services, PSC Biotech® acts as a seamless extension of your team — helping companies navigate FDA requirements, ensure cGxP compliance, and deliver high-quality products to patients.

Through BIO Business Solutions®, member companies gain exclusive savings and tailored project support, making PSC Biotech® a trusted partner in accelerating regulatory readiness and maintaining compliance.

PSC Resources

PSC Biotech® provides complimentary tools to help life science companies strengthen grant applications and improve funding success.

Need support? Contact the BIO Business Solutions Customer Success Team
Tamy Dalal
Tamy Dalal
202.962.6635 • General Inquires
Neil Lynch
Neil Lynch
202.365.6745 • Western US
Jim Seymour
Jim Seymour
845.239.3325 • Eastern US