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Quality & Compliance

Trident BioPharm Solutions provides support for global audit, training, SOP and remediation services. We assist our clients to develop, maintain and implement Quality Management Systems (QMS) that meet global ICH requirements. Our services include GCP audits, GLP audits, bioanalytical laboratory audits, central laboratory audits, CRO audits, vendor audits, sponsor audits, CSV audits and CDMO/CMO (GMP) audits.

We support with onsite teams to help with urgent remediation needs as well as remote auditing where feasible. Working across pharma, biologics, MedTech and diagnostics we can help establish sustainable processes, which reduce quality defects and mitigate costly compliance issues down the road.

1 

Inspection Readiness

  • Training of staff and interview preparation

  • Post-inspection review and remediation analysis (Root Cause Analysis (RCA), and CAPA support)

  • Expert consulting support to internal Quality and Tech transfer teams

2

Regulatory Agency Response, Remediation and Auditing

  • Support for GxP deviations (Warning letters, Consent decrees, 483’s)

  • Quick turnaround solutions for FDA/EMA audits (GCP/GLP/GDP/GMP)

  • Due diligence, supplier/vendor qualifications and third-party oversight

  • Pre-Approval (PAI) and Regulatory Audit Inspection Readiness Training

  • Annual product reviews

3

Technical Transfer

  • “Site to Site” or “Development to Product” technology transfer support

  • Project management of transfer process for both mature and new products

  • CMO/CDMO selection and Bid management

  • Gap analysis of donor and recipient site(s)

  • Process and scale up definition, specification and assessments

4

Validation and Compliance

  • Review and drafting of validation plans / master plans

  • Validation protocols (IQ/OQ) and design qualification

  • Support with process validation, review and drafting of validation reports and protocols (including retrospective validation)

  • SAT/FAT testing and protocols

  • Commissioning / Decommissioning services as required

  • Computer System Validation and Assurance

  • QP and QPPV services

  • Legal representative services in EU, North America and MENA

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Let's Work Together

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