Regulatory agencies have been working closely with pharmaceutical companies to support and expedite approval of innovative products and therapies. They are increasingly focusing on strengthening the approach and methods for the assessment of quality, safety, and efficacy of drugs, devices, and combination products. To meet unmet needs for novel, safe drugs and therapies, drug safety and regulatory departments at pharmaceutical companies work together to navigate and operate in a dynamic but continuously stringent regulatory environment.
Meeting complex regulatory requirements for drug safety can be challenging for all sizes of organizations. In addition to this, there are other challenges including financial constraints and pressures to advance products through discovery and clinical development, submission of applications to regulatory agencies, and developing successful launch plans to bring safe and effective products to patients. Successfully managing the drug safety profile of your program throughout the drug lifecycle is an asset. Having access to aggregate information across studies and at the same time reducing overhead and redundant fees pays dividends each time regulatory reports, scientific communications, and applications are prepared. Due diligence for partnership and investment purposes can be packaged for accurate financial assessment. Executives discuss knowns and unknowns with the assurance that a complete safety analysis of the data has been performed. Therefore, it is important to partner with a specialized pharmacovigilance services provider to review and analyze consolidated data, help to define the initial product label, and proactively identify, assess, and help to manage safety concerns.
Partnering with and outsourcing a critical function such as drug safety to a specialized pharmacovigilance services provider can help pharmaceutical companies in the following ways: