DDReg Pharma

Pharmacovigilance Services

We optimize safety databases and technical ability to deliver high-quality and reliable safety measures with minimal risk across ICSR Processing & Submission and have global presence in providing PV support.

DDReg provides Tailored and Compliant Pharmacovigilance Solutions to its Customers...

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).
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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.

Our drug safety and pharmacovigilance consulting services include:

ICSR Processing & Submission

Patient safety is of utmost importance and the root of all decisions along the entire drug...

Literature Monitoring

Medical literature is one of the primary sources of safety data. As regulations become increasingly...

Risk Management

Pharmaceutical products are associated with risks that must be managed efficiently to prevent...

Aggregate Reports

Detailed analysis of the benefit-risk evaluation for a pharmaceutical product cannot be conducted at...

Signal Management

Safety signals indicate that there is a potential adverse event linked to a pharmaceutical...

QPPV Services

Quality Person for Pharmacovigilance (QPPV) is responsible for the management of...

Audit and Compliance

The reason regulations are stringent is to ensure maximum patient safety along the entire drug development pipeline- from research to post-marketing activities.

QPPV Services

The appointment of a Qualified Person for Pharmacovigilance (QPPV) is mandatory by many global...

Audit and Compliance

The reason regulations are stringent is to ensure maximum patient safety along the entire drug development pipeline- from research to post-marketing activities.

Safety Writing

Safety writing primarily involves ICSR Narraive writing, Aggregate reports, RMP and signal report...

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