regulatory affairs strategies, global registrations, CE marking, communication with competent authorities / agencies, remediation activities, mock inspections etc.)
strategic and operational management, innovation management, project portfolio management.
new product development (idea through design and registration to commercialization), product maintenance, product life-cycle management
IEC 62366 and
(technical files, DHF, DMR)
with a focus on quality improvement and cost reductions
development of quality management systems
(ISO 9001, ISO 13485, 21 CFR Part 820, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 4, 21 CFR Part 11,
Council Directive 93/42/EEC (Annex II, IV, V, VI, VII, and VIII), SOR /98-282
(Canadian Medical Device Regulations), auditing, and gap analyses.
We seek to invest in equity participations in innovative companies in an early stage with strong growth opportunities. Currently, Yphelios hold direct and indirect investments in 5 businesses. Our portfolio comprises equity holdings in medical, technology, and real estate investments.
Sandoz, the generic pharmaceuticals division of Novartis, is a worldwide leader in generics and biosimilars. With a history of more than 120 years, Sandoz is a trusted leader with a reputation for exceptional quality. Sandoz’ strategic and customer-focused approach to developing, producing and marketing high-quality affordable medicines following the loss of patent protection is internationally renowned.VISIT WEBSITE
Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. Novartis was created in 1996 through the merger of Ciba-Geigy and Sandoz and has a rich history spanning over 200 years. Novartis operates businesses with global scale and strong customer ties, focusing on innovative patented medicines, generics and eye care devices.VISIT WEBSITE
Merz Pharma is an independent international aesthetics and neurotoxin company with its own research and development capabilities. Merz Pharma continued growth and market leadership in aesthetics and neurotoxins is the result of their drive for innovation, along with focused, strategic acquisitions. Merz Pharma have continued to expand across all areas of our business, due to a focused, purposeful approach that includes both organic and inorganic growth.VISIT WEBSITE
CeQur SA was established in January 2008 by Jim Peterson who saw the need to improve the quality of life for people with diabetes and who has a long history of working with the Joslin Diabetes Center and the diabetes community. CeQur is dedicated to helping people with type 2 diabetes manage their disease by developing and commercializing simple drug delivery devices that can be easily integrated into daily life.VISIT WEBSITE
MED-RAS GmbH was founded in 2002, with the target to support businesses in the health sector in their compliance with legal requirements.To provide this, MED-RAS GmbH works closely with experts who have long-term experiences in their field. Their primary focus is in the areas of risk based quality management, regulatory affairs guidance during design and development and preparation of technical documentation.VISIT WEBSITE
Founded in 1944, NSF's mission is to protect and improve global human health. Manufacturers, regulators and consumers look to us to develop public health standards and certifications that help protect food, water, consumer products and the environment. As an independent, accredited organization, NSF tests, audits and certifies products and systems as well as provide education and risk management.VISIT WEBSITE
Confinis is an international consultancy specializing in providing professional services and advice to companies in medical device, pharmaceutical, biotech and diagnostic industries. confinis' core competences are in global regulatory affairs, quality management, project management, interim management, software life-cycle management, design control and risk management. Furthermore it is a recognized expert regarding drug delivery devices.VISIT WEBSITE
Yphelios Limited is registered as a Limited with the company registration 1689608 in Hong Kong. The company is managed by a Board of Directors reporting to the Chairman.
Yphelios provides a broad range of consultancy services to help you meet all your regulatory requirements needs.
Yphelios complies with the highest standards of compliance, governance and quality management.