ICSR Processing & Submission
Patient safety is of utmost importance and the root of all...
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DDReg provides Tailored and Compliant Pharmacovigilance Solutions to its Customers
Pharmacovigilance solutions 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 services 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 is a globally reputed and leading pharmacovigilance consulting firm that provides compliant and reliable pharmacovigilance consulting 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. Being one of the top pharmacovigilance consulting companies, 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, being a pharmacovigilance consulting firm, provide comprehensive QPPV Services that also include reviewing SDEA agreements, QPPV/RPPV and PSMF changes, retainer services, and medical review & surveillance for signal management.
Our drug safety and pharmacovigilance consulting services include:
Literature Monitoring
Medical literature is one of the primary sources of safety data. As regulations become increasingly...
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Risk Management
Pharmaceutical products are associated with risks that must be managed efficiently to prevent...
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Audit and Compliance
The reason regulations are stringent is to ensure maximum patient safety along...
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Signal Management
Safety signals indicate that there is a potential adverse event linked to a pharmaceutical...
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QPPV Services
Quality Person for Pharmacovigilance (QPPV) is responsible for the management...
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Aggregate Reports
Detailed analysis of the benefit-risk evaluation for a pharmaceutical product...
Read More ➔Global Pharmacovigilance Regulations and Post Marketing Safety Requirements
Navigating global pharmacovigilance...
Read More ➔Basics of Pharmacovigilance Services
Pharmacovigilance services play an important role in ensuring the safety and efficacy of pharmaceutical products in post-market approval stages. These services, often provided by pharmacovigilance consulting companies, systematically monitor, and continuously assess adverse effects to help detect potential risks as early as possible. The timely detection and reporting of adverse events allow competent authorities to take efficient measures and decisions such as withdrawing a pharmaceutical product or modifying its safety information.
DDReg is a regulatory and pharmacovigilance consulting firm that also specializes in providing customers with end-to-end solutions. The team leverages their expertise in regulatory compliance, risk management, and technological advancements to help establish robust pharmacovigilance systems that are compliant with global safety standards and regulations. The dedicated team supports global pharmaceutical companies with reporting of adverse events, signal detection, risk mitigation, and integrated technologies & software for data collection, analysis, and reporting.
DDReg has also supported its customers by providing pharmacovigilance raining, quality assurance (QA) audits, and strategic advisory services to enhance pharmacovigilance capabilities. The team at DDReg addresses all critic components related to pharmacovigilance to maintain regulatory compliance and safeguard patient safety.
How does DDReg stand apart from other pharmacovigilance consulting companies?
DDReg is committed to innovation, unwavering quality, and adopts a customer-centric approach. We give utmost importance to incorporating technological innovators to streamline pharmacovigilance processes which ensures compliance and an agile response to compliance & safety-related challenges. The pharmacovigilance teams constitute seasoned professionals that possess extensive expertise in regulatory affairs and pharmacovigilance which guarantees meticulous adherence to global standards. DDReg builds and maintains client relationships with transparency and collaboration by providing regular updates and insights that empower clients. This is supported by the team’s deep understanding of and experience in pharmacovigilance.
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