DDReg Pharma- Consulting in regulatory affairs and drug safety

Pharma regulatory affairs is centered around the common technical document (CTD) that is required for the registration of pharmaceutical products in all markets. In more recent times the shift from the CTD to the electronic CTD (eCTD) is being adopted by regulatory agencies worldwide to overcome challenges associated with large amounts of paper-based data and to help facilitate more harmonized and efficient submissions. This is because it enhances review and submission processes, results in more accurate & precise submissions, mitigates duplicate submissions (due to better document organization), and implements a single, standard format that is accepted worldwide. Implementing the eCTD 4.0 What is the eCTD 4.0? The eCTD 4.0 is the most recent eCTD standard that address some of the key limitations. It’s main goals are to implement changes that accelerate and maximize the efficiency of regulatory submissions; enhance the communication channel between sponsors and regulatory agencies...

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...

Pharmaceutical organizations that are not compliant with regulations set by the authorities can face severe consequences that can significantly impact the organization in terms of cost and reputational damage. Regulatory service providers must also ensure that their services and quality systems are compliant with regulations and current good manufacturing practices (cGMP). Companies that are not cGMP compliant or follow strict quality parameters could be problematic and lead to product recall. Therefore, it is important to partner with a pharma regulatory affairs consulting team or service that can, for example, assist in responding to queries or regulatory conc erns or navigate through quality system audits to ensure regulatory compliance is met. When identifying the right regulatory consulting firms it is important to make sure that they possess recent and extensive experience in the regulatory domain. They must also be able to demonstrate their knowledge of the regulatory land...

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...