ICSR Processing & Submission
Patient safety is of utmost importance and the root of all...Read More➔
Pharmacovigilance takes drug safety to another level and actively detects potential safety signals and any trends related to the drugs in their post-marketing stage. In order to effectively manage and deliver pharmacovigilance activities for drug and patient safety, it is important to have robust pharmacovigilance systems and processes in place that are compliant with the requirements of international standards such as the ICH, GVP, and global agencies such as the US FDA, EMA, UK MHRA etc.
DDReg provides compliant and reliable pharmacovigilance services for its customers in management all drug safety operations. Our ICSR Case Processing services cover all stages, from data entry to final case submission to agencies through E2B(R3) compliant case processing databases that are integrated with MedDRA and WHO DD coding and have XML file import and export functionalities. Our literature monitoring services include EMA’s Medical Literature Monitoring and product literature monitoring from MAAs to post approval stages. Our PV & Risk management capabilities include continuous and meticulous evaluation of drug product risks as well as compiling, authoring, and conducting quality checks of Risk Management Plans (RMPs) and Risk Evaluation Mitigation Strategies (REMS), signal detection, evaluation and reporting. We assist in developing PV and drug safety systems by implementing standard operating procedures (SOPs) and working guidelines, compliant quality management systems, and pharmacovigilance system master files (PSMFS).
Our team of medico-regulatory and safety writing experts support in authoring and compiling pharmacovigilance aggregate reports such as Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Periodic Benefit Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs). We provide comprehensive QPPV Services that also include reviewing SDEA agreements, QPPV/RPPV and PSMF changes, retainer services, and medical review & surveillance for signal management.
Medical literature is one of the primary sources of safety data. As regulations become increasingly...Read More➔
The reason regulations are stringent is to ensure maximum patient safety along...Read More➔
Safety signals indicate that there is a potential adverse event linked to a pharmaceutical...Read More➔