Quality & Regulatory Consulting
Quality & Regulatory Consulting
Strategic and operational consulting to strengthen quality management systems, close compliance gaps, navigate regulatory requirements and build lasting inspection readiness.
Executive Overview
Regulatory compliance in the pharmaceutical and medical device sectors is not a static state, it requires continuous attention, system maintenance and proactive management of regulatory change. Organisations that treat compliance as a fixed set of procedures rather than a dynamic quality system consistently find themselves reactive rather than prepared when regulatory scrutiny arrives.
Sthira Assure quality and regulatory consulting services support organisations in designing, building and strengthening the quality systems that underpin regulatory compliance. We work with pharmaceutical manufacturers, biotechnology companies, medical device firms and their supply chain partners on gap assessments, QMS design, regulatory strategy and operational improvement programmes.
Our approach is grounded in practical regulatory experience. We provide recommendations that can be implemented within your operational context, not generic advice derived from regulatory text alone. The goal is not documentation for its own sake, but quality systems that function as designed and that stand up to scrutiny from the most experienced regulatory inspector.
Who We Work With
- VP Quality & Compliance
- Head of Quality Assurance
- Regulatory Affairs Directors
- Quality Directors
- Qualified Persons (QPs)
- Responsible Persons (RPs)
Consulting Services
Gap Assessments
Systematic assessment of quality management systems against current regulatory requirements. Identifies compliance gaps, assigns regulatory risk ratings and provides a prioritised remediation roadmap.
QMS Design and Implementation
Design of quality management systems aligned to ICH Q10, ISO 9001 and sector-specific regulatory requirements. From system architecture through SOP development and implementation support.
Regulatory Strategy
Strategic guidance on regulatory pathway selection, submission planning, agency interaction and compliance programme design for organisations entering new markets or product categories.
Quality System Reviews
Comprehensive review of existing quality systems, SOPs, quality manuals, process controls, KPIs and quality metrics, to assess fitness for purpose and alignment with current regulatory expectations.
Training and Workshops
Targeted training programmes for quality, regulatory affairs and operational teams on GxP requirements, quality system operation, inspection preparation and regulatory risk management.
Quality Manual and SOP Development
Development and revision of quality documentation, quality manuals, standard operating procedures, quality plans and process maps, aligned to applicable regulatory frameworks and your operational context.
Discuss Your Quality System Requirements
Contact our team to discuss your quality management challenges and how we can support your compliance programme.