DDReg Pharma- Consulting in regulatory affairs and drug safety

The market for medical device is expanding rapidly leading to anticipated growth in the market size. Medical devices significantly contribute to patient health; the support and benefits they can offer are continuing to grow as they are required in diagnosis, treatment and prevention of diseases and disorders in a safe and effective way. Any instrument, machine, appliance, apparatus, implant, or other related object, that are intended to use for a specific medical purpose, either alone or in combination is called a medical device. They can be used in a variety of medical settings, including common medical procedures such as bandaging a sprained ankle, diagnosing disorders such as HIV/AIDS, monitoring of heartbeat, or for any surgical intervention. Pharma regulatory affairs serve a critical function throughout a healthcare product lifecycle- leading premarket strategy, drafting regulatory submissions, and ensuring post market compliance. The process of regulatory affairs is an essential...

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, compilat...