Black Mountain Pharma Ltd is a specialist consultancy providing Regulatory Affairs and Quality Assurance services for the Medical Device and Pharmaceutical Industry.
With a network of global regulatory affairs and quality consultants, with over 50 years combined experience, our team of Regulatory Affairs and Quality specialists’ is totally focused on providing a first-class, excellent value and confidential service to meet the needs of our clients.
Whether you are a small or large company, our objective is to ensure you build and sustain quality management systems and regulatory strategies to meet your business goals.
Company’s Keywords:
medical devices, quality management systems, iso13485, iso17025, eu gmp 2003, 94, ec, medical device regulation, risk management, clinical evaluation, biological evaluation, technical files, iso 14971, brexit strategy, design & development for medical devices, global regulatory strategy, authorised representative
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