BioTech Regulatory Consulting
At QAEC Limited we provide specialised regulatory and quality consultancy support to BioTech companies, helping you navigate complex regulations and maintain high-quality standards throughout your product’s lifecycle. Whether you’re a university spin-out, start-up or an established business, we offer tailored solutions to help ensure compliance and streamline your pathway to market.
Regulatory Support Services:
- Regulatory Strategy: Customised plans for global market access, including FDA, EMA (European Medicines Agency), and MHRA submissions.
- Regulatory Submissions: Assistance with IND (Investigational New Drug), CTA (Clinical Trial Application), BLA (Biologics License Application), and NDA (New Drug Application) filings to meet approval requirements.
- Compliance Management: Ensuring adherence to evolving regulations, including labelling, reporting, and post-approval changes.
- Regulatory Intelligence: Monitoring changes in global regulations and providing actionable insights.
Quality Support Services:
- Quality Management Systems (QMS): Development and implementation of ISO 13485, GMP, and ICH (International Council on Harmonisation) Q10-compliant systems (integrated pharmaceutical quality management mode).
- GMP Compliance: Auditing, process validation, and supplier qualification to meet Good Manufacturing Practice standards.
- Risk Management: Comprehensive risk assessments and CAPA management to ensure product safety and efficacy.
- Internal & Supplier Audits: Ensuring continuous quality improvement and readiness for regulatory inspections.
With a focus on BioTech industry standards, our expertise in quality and regulatory helps ensure your products are safe, effective, and compliant, from development through post-market activities.
Contact us today at +44 (0)1452 341913 or enquiries@qaeclimited.co.uk to learn how we can support your BioTech projects.
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