Committed to Your Growth

At BioTech Advice, we turn your challenges into sustainable success. Discover our specialized consulting services, designed specifically for pharmaceutical and medical device industries operating in regulated environments. Our deep expertise, close client partnership, and critical thinking are the keys to your progress and compliance.

Our Areas of Expertise

We offer a comprehensive range of consulting services, each designed to address your specific needs and bridge critical gaps in resources or expertise. Explore our service pillars and see how we can help you excel.

Organizational Leadership

Key Deliverables include:

  • Organizational assessments and leadership diagnostics
  • Governance models and decision-making frameworks
  • Strategic roadmaps and execution plans
  • Change management and transformation support
  • Executive coaching and advisory support

CAPEX Project Management

Key Deliverables include:

  • Business cases, and CAPEX Wishlist
  • Project charters, schedules, and budgets
  • Risk assessments and mitigation plans
  • Vendor coordination and project governance reporting
  • Project execution, commissioning handover, and close-out documentation

Quality Compliance

Key Deliverables include:

  • Deviation, CAPA, and change management
  • Data integrity governance (ALCOA+)
  • ICH Q9–aligned risk assessments
  • Supplier qualification in accordance with GMP and quality system requirements.
  • Criticality and impact analysis
  • Risk-based decision support
  • QC organization and process optimization
  • System Audit Trails, Accesses, Qualification, or/and Validation Periodic Reviews

Qualification and Validation

Key Deliverables include:

  • ISPE guideline–based qualification and validation approach.
  • Validation planning (VP) and reporting (VR).
  • User Requirements Specifications (URS)
  • System Classification
  • FMEA-based risk assessments addressing GxP impact, functional criticality, and data integrity, with documented alignment to 21 CFR Part 11 and EudraLex Annex 11.
  • C&Q and CSV IQ/OQ/PQ protocols, execution, and reports writing
  • Traceability matrices and regulatory-ready documentation
  • NC, CAPA, and integrated Change Control Management

Your trusted partner in Switzerland

Based in Basel, Switzerland, we are proud to deliver tailored advisory services that fulfill our clients’ expectations. BioTech Advice stands for a trusted partnership and a more confident future for your organization in an ever-evolving environment.

Quality Risk Management

Navigate regulated environments with unwavering confidence. Our proven quality risk management strategies protect your reputation, ensure robust compliance, and optimize your operations.

Overcome your challenges

Do you lack the internal resources or expertise for your critical projects? BioTech Advice steps in precisely where you need support. Our services are tailored to the pharmaceutical and medical device industries, delivering practical solutions that drive progress.