We provide comprehensive life sciences services to ensure compliance and success in the medical device, cosmetics, pharmaceuticals, and biotechnology industries.
With our expertise and tailored solutions, your organization can successfully navigate regulatory challenges whether you are a start-up, established company or expanding into new markets.
Industry Services
Quality Management Systems Development
We develop integrated quality management systems in compliance with international standards (ISO 13485:2016; ISO 22716:2007), recognized guidelines (ICH, IMDRF, MDCG) and regulatory requirements applicable to relevant jurisdictions (21 CFR Part 820, EU MDR, UK MDR 2002, Canadian MDR).
Regulatory Support
Our regulatory support services span from addressing FDA inspection findings to navigating the regulatory pathway to gain market access, primarily medical devices cosmetics and OTC drugs.
Supplier Scouting and Qualification
Our expertise extends to supplier scouting and qualification, helping organizations identify and partner with reliable suppliers who meet stringent quality and regulatory requirements.
Pre-Market and Post-Market Support
We offer product pre-market services such as regulatory pathway identification, submission assistance identification of authorized representatives and, notified body needed for market authorization. Additionally, our post-market services encompass internal audits, quality management system improvements, regulatory and certification/notified body findings support, post market surveillance reporting.
For more information regarding pre-market services, visit our Startups page.
Additional Services Include
- Assistance with submissions for new medical devices in multiple regions, including the United States, Canada, the UK, European Union, and Saudi Arabia.
- Risk management strategies to mitigate regulatory and operational risks.
- Internal auditing to ensure ongoing compliance and continuous improvement.
- Training on subject matter related to quality management systems and regulatory compliance.
- Assistance with MedAccred accreditation for critical process manufacturing operations in the production of medical devices.
Our Customers
With our expertise and tailored solutions, your organization can successfully navigate regulatory challenges whether you are a start-up, established company or moving into new markets.
