Regulatory Affairs Healthcare and Pharma

The regulation of medical drugs and devices aims to assure the safety and efficacy of products, while also facilitating the movement of innovative therapies through the investigative and regulatory processes as quickly as possible.

The exponential advance of developments in science and technology, alongside the blurring of traditional barriers between existing and new healthcare providers, is increasing the need for new regulatory frameworks and greater clarity about how the changes will impact relationships between regulators and industry, patients, and other stakeholders.

The life sciences industry operates in an increasingly proliferation of complex regulatory changes; over the past few years, the industry has seen a plethora of new regulations  of innovative technologies, products and processes that are due to come into force. At the same time, regulators face the challenge of continuing to protect patients and enhance public health, while fostering innovation by responding quickly and effectively to the exponential pace of change in medicine, science, and technology.

Healthcare, pharmaceuticals, and biotech companies and regulators need to work collaboratively, to cope with the complexity of disruptive technologies and new generation treatments.

Handling the Challenge of Regulatory Affairs

Oliba helps healthcare and pharma industries to handle the key challenges of regulatory affairs.
There are currently three key challenges for healthcare and pharma industries:

  • Increasing regulatory requirements and a more complex understanding of science are leading to yearly increases in costs and declines in average peak sales per asset.
  • The adoption of emerging technologies is influencing the future of R&D. Real-world evidence, data analytics tools and advanced therapies  are impacting the whole R&D value chain from study design, physician and patient recruitment, and in-trial decision making, to automating repetitive tasks such as regulatory filing.
  • Information from social media, mHealth, wearables, connected medical devices and telemedicine are transforming how physicians and patients are engaged and retained in clinical trials. This includes how they report positive and negative outcomes.

Satisfying regulatory hurdles is a complex task and requires specific competences and a resourceful network  : this is why more and more healthcare and pharma organizations are asking Oliba to supporting them in managing their Regulatory Affairs. If you are looking for help to manage Regulatory Affairs in the Healthcare and Pharma sector, Oliba can deploy top experts to manage this activity for your organization.

Oliba’s team possess the skills and experience to advise, design, and supervise the following stages:

  • Research and development
  • Clinical Trials and healthcare regulatory submissions
  • Marketing & advertisement campaigns and distribution
  • Post-market surveillance

Contact us to find the best solution to manage Regulatory Affairs in Healthcare and Pharma sector for your company.