Pharmaceutical company resources continue to decrease, regulatory rules have become stricter and complex such as approval processes and post-approval requirements.
To address these issues, minimizing their negative impact, pharmaceutical firms are proactively and significantly changing their business models, trying to increase partnerships focusing on improving collaborations.
Pharma industry is gaining so far a “buy model”: outsourcing can provide a solution, delivering a competitive advantage for companies that lack the resources or expertise to guide a product to approval and to the market.
Partnering with regulatory experts can also save valuable time and unnecessary work.
In case there are recent legislation changes, dedicated experts are continually updated and more experienced in dealing with Authorities. They can advise a company on strategic and specific information that Competent Agencies will be expecting to see in a submission.
From a practical stand point, regulatory documents and scientific communications require a high level of precision and adherence to format, which may be best left to an experienced partner.
Outsourcing provides a wide range of benefits from flexibility, on-demand capacity and anticipating and preventing hurdles, saving time and costs.
RPN is your right partner since it works to ensure the goal achievement, by starting early, discussing the process and setting checkpoints, becoming an extension of Client organization.