Quality Assurance Support

Tower Mains prides itself on offering flexible, credible and cost-effective quality assurance unit support services. We provide QA resource when and where you need it – from short ad hoc projects, to long term QA collaborations across both regulatory and non-regulatory environments.

GLP

Independent audits assure Test Facility Management (TFM) that work is being performed in accordance with their expectations and requirements. To support this, Tower Mains provide audit services on a study and non-study specific basis. For example:

  • Study Based Audits

    • Study Plan & Amendment Review
    • Critical Phase Audits
    • Raw Data & Report Audit

  • Process Based Audits

  • Facility Based Audits

    • Independent Audit of your QA Unit

  • Computer System Validation Audits

  • Regulatory and Vendor Audits

    • Mock Inspections
    • Live inspection support

  • QMS Documentation Support

    • SOPs
    • Policies
    • Standard Forms & Templates
  • Ad hoc consultancy Services

    • General advice and support on Quality Assurance and Regulatory matters

Our team supporting GLP organisations have experience in the following areas:

  • Toxicology
  • Genetic Toxicology
  • Developmental and Reproductive Toxicology (DART)
  • Bioanalytical

  • Pharmacokinetic/Toxicokinetic

  • Metabolism

  • Immunohistochemistry

  • Field Trials

  • Ecotoxicology

  • Environmental Fate & Metabolism

  • Residue Studies

  • Biocidal Products

  • ISO 10993

GMP

QA support options available include:

  • Routine QS activities

    • CAPA management, investigation co-ordination, document control

  • Internal Audits

    • Tower Mains can assist with the planning, conduct & review of these audits as applicable

  • Ad hoc Consultancy Services

    • General advice and support on quality and regulatory matters

  • Regulatory and Vendor Audits

    • Mock Inspections
    • Live inspection support

  • QMS Documentation Support

    • SOPs
    • Policies
    • Standard Forms & Templates

GCP

QA support options available include:

  • Routine QS Activities

    • CAPA management, investigation co-ordination, document review & control

  • Investigator Site Support & Advice

  • Internal Audits

    • Tower Mains can assist with the planning, conduct & review of these audits as applicable

  • Regulatory, Investigator Site and Vendor Audits

    • Mock Inspections
    • Live inspection support

  • QMS Documentation Support

    • SOPs
    • Policies
    • Standard Forms & Templates

  • Ad hoc Consultancy Services

    • General advice and support on quality and regulatory matters
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