PROHEALTHA LIFE SCIENCES offers a full range of regulatory services for medical device
companies. Our strategic regulatory services provide expertise in the overall planning and
execution of regulatory compliance through all phases of the device lifecycle. This includes
intensive consultation for both interventional and diagnostic devices.
STRATEGIC REGULATORY CONSULTATION
Plan for Regulatory Compliance Executive and investor briefings, including high-level
interactive discussions on key issues associated with the integration of regulatory
compliance into product development, approval and marketing programs.
AUDIT AND ASSESSMENT
Conduct independent and objective audits for conformance with medical device regulatory
requirements:
Our services Include. :
REGULATORY SERVICES
Our services Include. :
EXIT TARGET IDENTIFICATION AND ENGAGEMENT
We use our medical device sector knowledge and experience to identify exit or licensing
target companies and engage with the right individuals in the organization. Often target
companies are large multinationals and multiple points of contact are required to influence
the different stakeholders in the decision making process. Our consultants understand the
workings of large companies and plan engagement on an individual basis.
HEALTH ECONOMICS
Healthcare agencies and payers are demanding economic analyses of the cost/benefit and
budgetary impact of new medical devices. Safety and efficacy studies are no longer sufficient
for optimal market access, so our consultants provide the information and insight necessary
to address these issues.
TECHNOLOGY ADVISORY
Technology moves on fast in the medical device industry and it is crucial that senior
management keep pace with developments and understand the potential impact on the
competitiveness of their business. We have medical device consultants in all of the key
technology areas and can advise on how emerging technology developments are likely to
influence the dynamics of clients’ markets.
