The importance of outsourcing regulatory solutions

The pharmaceutical industry is one that faces constant change across all its areas. Whether it’s the impact of geopolitical movements such as Brexit, incorporation of new technology, or ever-changing regulations that create challenges for marketing authorization holders. Pharmaceutical businesses are increasingly outsourcing regulatory affairs as they do not have the infrastructure or resources in place for regulatory operations, and want to maximize the efficiency of their processes. Outsourcing regulatory solutions is becoming a common and successful practice for businesses; even for larger organizations that have regulatory divisions in place, they face new challenges when entering emerging or novel markets.

Both small and large companies establish a relationship with outsourcing service providers for a variety of regulatory services to minimize cost and maximize resources to drive the business forward. This can include medico-regulatory writing, literature searches, compilation of regulatory documents, and compliance-based processes from drafting and implementing standard operating procedures (SOPs) to conducting audits of organizations and pharmacovigilance systems. Additionally, pharmaceutical businesses look to outsource liaising activities with global regulatory authorities, developing regulatory strategies, regulatory intelligence and more. Successful outsourcing requires pharmaceutical businesses to correctly identify partners that can not only provide the technical expertise but also be reliable and transparent in their ways of working.

Many regulatory consulting organizations specialize in different areas of regulatory affairs. Ideally, consultants and services providers should be familiar with all requirements of all the major and emerging regulatory markets. This also includes staying updated with changes in regulations as a result of geopolitical movements. For example, with Brexit, how have the requirements for marketing authorization holders changed for products intended for sale in EU markets vs UK markets? What is changing in emerging pharmaceutical markets that require immediate attention? How will this create opportunities for pharmaceutical businesses and their outsourcing partners?

Outsourcing regulatory services is the preferred choice for large and small organizations. However, it is crucial for them to ensure that the service providers they choose to partner with are qualified, experienced, and knowledgeable on their regulatory services, the regulatory market, and the importance of maintaining regulatory compliance. 

Regulations and legislations surrounding pharmaceutical products are becoming more stringent, creating delays in achieving market authorizations. DDReg provides end-to-end regulatory services to obtain rapid market access for Rx Generic, OTC/GSL Medicines, Biosimilars and vaccines. We have managed regulatory compliance for 2000+ licenses globally and delivered 200+ authorizations in the EU & the US, and 600+ MAs in emerging markets including GCC, Africas, LatAm, CIS & ASEAN. Furthermore, we have a highly qualified pharmacovigilance team that ensures regulatory compliance along the entire product lifecycle and ensures robust pharmacovigilance measures are in place for the organization.

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