We provide comprehensive life sciences services to ensure compliance and success in the medical device, cosmetics, pharmaceuticals, biologics, 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 moving into new markets.
Product Services
Quality Management Systems Development
We develop UM quality management systems in compliance with medical device industry regulations, ensuring adherence to ISO 13485 and FDA quality management system regulation standards.
Regulatory Support
Our regulatory support services assist customers in addressing FDA inspection findings and navigating market entry in various sectors, including medical devices, cosmetics, pharmaceuticals, biologics, and biotechnology.
Integrated Management Systems
We design integrated management systems that consider industry-specific standards, such as ISO 22716 for cosmetics and ICH guidelines for pharmaceuticals, while also ensuring compliance with FDA regulations.
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 pre-market services such as regulatory pathway identification, submission assistance, and market authorization achievement. Additionally, our post-market services encompass internal audits, quality management system improvements, regulatory findings support, clinical evaluations, and entry into new markets.
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 EU Medical Device Regulation (MDR) and corrective actions implementation.
- Assistance with Medicred compliance and Good Manufacturing Practices (GMP) adherence.
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.
