Black Mountain Pharma
Regulatory affairs and quality assurance consultancy serving medical devices, cosmetics, food and pharmaceutical sectors. Services include development and maintenance of quality management systems, regulatory submissions and representation, technical documentation for device and cosmetic products, audit/inspection support, and training. The organisation provides EU and UK regulatory representation and supports clients with compliance to European directives and standards.
Industries
Nr. of Employees
small (1-50)
Black Mountain Pharma
Llandovery, Carmarthenshire, United Kingdom, Europe
Services
Advisory services covering regulatory strategy, documentation, representation and compliance for devices, cosmetics, food and pharmaceutical products.
Gap assessments, system design and assistance for transition to or certification against standards such as ISO 13485:2016 and ISO 17025:2017.
Preparation, mock audits and remediation planning to address findings from regulatory inspections.
Training programs and team development in areas of regulatory compliance, QMS and post-market surveillance.
Advisory services covering regulatory strategy, documentation, representation and compliance for devices, cosmetics, food and pharmaceutical products.
Gap assessments, system design and assistance for transition to or certification against standards such as ISO 13485:2016 and ISO 17025:2017.
Preparation, mock audits and remediation planning to address findings from regulatory inspections.
Training programs and team development in areas of regulatory compliance, QMS and post-market surveillance.
Expertise Areas
- Regulatory affairs for medical devices, cosmetics, pharmaceuticals and food
- Quality management system implementation and certification (ISO standards, GMP/GDP)
- CE marking and European Medical Device Regulation (MDR) compliance
- Clinical evaluation and biological safety assessment for devices
Key Technologies
- ISO 13485 quality management systems
- ISO 17025 laboratory accreditation
- ISO 10993 biological evaluation methods
- ISO 14971 risk management methodology