Expert Life Sciences Consulting
Guiding you through Quality & Regulatory Excellence
Expert Life Sciences Consulting
Guiding you through Quality & Regulatory Excellence
About ISOLA Life Sciences Consultants
Our Mission
Our Approach
Our Mission
At ISOLA Life Sciences Consultants, our mission is to empower life sciences companies to achieve excellence in Quality and Regulatory Affairs. We are dedicated to providing tailored solutions that enhance compliance and facilitate market access.
Our Team
Our Approach
Our Mission
Our team of experienced consultants has a diverse range of expertise. We work together to develop customized solutions for each client, based on their unique needs and goals.
Our Approach
Our Approach
Our Approach
Our approach is strategic, proactive, and tailored to your unique needs. We go beyond compliance, integrating risk-based strategies that align with your business goals.
Our Services
Quality Management
- Development and implementation of Quality Management Systems (QMS) in compliance with international standards (ISO 9001/ ISO 13485, EU MDR/ IVDR, 21 CFR 820, MDSAP etc.,).
- Coaching/training in preparation for ISO 13485 certification, including support with management reviews, and supplier qualifications.
- Implement and maintain Risk Management processes in compliance with ISO 14971.
- Conducting internal and supplier audits to ensure regulatory compliance.
- Provide hands-on support during audits and inspections and assist in remediating non-conformities.
- Structure Technical Documentation per international regulatory requirements.
- Establish and maintain Post-Market Surveillance processes, including complaint handling, adverse event reporting and FSCAs.
- Facilitate data-driven continuous QMS improvements.
- Training programs on Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and Good Clinical Practices (GCP).
Regulatory Affairs
- Regulatory strategy development for product approvals in the EU, U.S., and other global markets (Australia, Canada, GCC, India etc.,).
- Prepare Technical Documentation and submissions for CE marking under MDR/ IVDR and/ or FDA 510(k), PMA applications.
- Liaison with notified bodies and regulatory agencies.
- Support FDA interactions, including Q-submissions, 510(k), De Novo, PMA, BDD, STeP, and 513(g) applications.
- Support V&V activities, including product specific verification activities, and usability validation per IEC 62366.
- Post-market surveillance and regulatory compliance maintenance.
- Post-market clinical follow-up (PMCF) and real-world evidence (RWE) studies.
- WHO Pre-Qualification for IVDs
- Deliver Regulatory Affairs training tailored to your needs.
Digital Health
- Guidance on information security and data protection compliance (e.g., GDPR, HIPAA).
- Implementation of Information security (ISO 27001), privacy information (ISO 27701) and Artificial Intelligent (ISO 42001) management systems.
- Training and advisory services on artificial intelligence (AI) and machine learning (ML) applications in life sciences.
- Risk assessment and mitigation strategies for digital health technologies.