Regulatory Affairs & Quality Assurance Consultancy Services for

the medical devices, cosmetics, food & pharma industries.

Since the founding of Black Mountain Pharma in 2012, our global team of professional regulatory affairs and quality assurance consultants from our medical device, cosmetics, pharma and food divisions have a long history of developing, implementing and sustaining quality management systems and establishing regulatory affairs strategies for businesses associated with medical devices, pharmaceuticals, cosmetics and foods.  

Whether you are a small, medium or large company, developing new products through design control,  preparing technical documentation, establishing new quality systems, GDP, preparing for audits/inspections, setting new post-market surveillance/vigilance systems, devising claims & product labelling or seeking regulatory approval for new products worldwide, we are here to help!!

We have recently (in 2018) founded our new office in Dublin, Ireland to ensure we support our clients outside the EU, and this will include UK-based clients  requiring EU Rep services after the brexit transition on the 29th March 2019.

We can assist with:

The development, implementation and ongoing maintenance of quality management systems including ISO 13485:2016, ISO 17025:2017, ISO 9001, ISO 22716, ISO 22000 and GMP, GDP and Wholesale Dealers licenses for Pharmaceuticals.

Acting as legal manufacturer, authorized representative or responsible person for medical devices, medicines and cosmetics in the EU and following Brexit we can act as a UK Responsible Person for overseas manufacturers.

The development of medical device product technical files, clinical evaluation reports (CER) according to MEDDEV 2.7/1 revision 4 , biological evaluations according to ISO 10993-1, risk management according to ISO 14971 and any other documents required for CE marking including gap assessments for the new European Medical Device Regulation.

The development of Product information files, product safety reports and labelling reviews for cosmetics.

Audit and regulatory inspection preparation and remediation.

Training and team development in all aspects of global regulatory affairs and quality assurance.

By partnering with our network of global regulatory affairs associates across central Europe, Asia, the Middle East and Latin America we can help develop your global regulatory strategy and product licencing for business growth worldwide.

About Us

Client focused & results driven