medical affairs outsourcing, pharma market solutions, pharmaceutical services and consulting, pharmaceutical validation, pharma supply chain management, marketing of pharmaceutical products, regulatory affairs pharmaceutical, preclinical research companies, pharma marketing solutions, global pharmaceutical company, aseptic filling process in pharma, biomarker analysis in clinical trials, biotech companies, patent and intellectual property, chemistry manufacturing and controls training, cleaning validation, cleaning verification in pharmaceutical industry, regulatory affairs cmc, clinical data management, clinical research organisations London, clinical research management system, clinical trial companies, clinical trials in the uk, consultancy pharmaceutical industry, consultant for pharmaceutical industry, consultant pharmaceutical, consultant regulatory affairs, consulting services pharmaceutical industry, continuous manufacturing in pharma, contract research organisations uk,

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.

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

products of pharmaceutical industry, project on pharmaceutical industry, pv quality management system, qms pharmaceutical, qms pharmaceutical industry,quality management system for pharmaceutical industry, quality management system gmp, quality management system in pharmaceutical industry pdf, quality management system pharmaceutical, quality management systems in pharmaceutical industry, quality system in pharmaceutical industry, quality systems pharmaceutical industry, regulatory affairs cmc, regulatory affairs consultancy uk, regulatory affairs consulting, regulatory affairs expert, regulatory affairs in medical devices, regulatory affairs in pharma, regulatory affairs in pharma industry, regulatory affairs in pharmaceutical industry, regulatory affairs pharma, regulatory affairs pharmaceutical, regulatory affairs services, regulatory affairs work, regulatory consultant, regulatory consulting, regulatory consulting services, regulatory in clinical research, regulatory market pharma

Let's Work Together