Bringing products to market in the life sciences sector requires navigating complex regulations, ensuring quality, and staying competitive in a fast-evolving industry. At Regulatus we provide tailored consultancy services to support every stage of the product lifecycle. Whether you’re looking for strategic guidance, regulatory support, or operational improvements, our team of industry experts is here to help.
We can provide any level of consultancy services to suit your needs, from a simple on-call advice line through to the provision of a fully outsourced quality and regulatory department. Our team possess a broad range of skills and experience encompassing the following:
- Regulatory strategy development and refinement.
- Quality management system implementation and remediation.
- Design and development coordination and support, including verification and validation
- Manufacturing process engineering and validation.
- Supplier and supply chain management.
- Market registration, authorization and support in achieving conformity assessment certification.
- Post-market surveillance and reporting, including mandatory problem/incident reporting
- Technical documentation compilation and remediation, including specialist processes such as:Bench testing and non-clinical data gathering
Biocompatibility, including toxicological risk analysis
Clinical and/or performance evaluation and investigation studies
Sterility assurance validation & microbiological control
Electrical safety & electro-magnetic compatibility
Software lifecycle validation
Human factors / usability engineering
