Pharmacovigilance involves a collection of data on Adverse Reactions to create safety information. Adverse drug reactions are one of the ultimate causes of morbidity and mortality. It should be detected early. Signal detection is the method of actively exploring and identifying safety signals from a wide range of data sources.  Furthermore, applying signal detection specifically for special population including pregnancy, pediatric and geriatric populations have special characteristics that should be determined. The steps are taken and must be accurately tracked and recorded at every stage. We at Atop Pharma Solutions can help you with drug safety data, analytics, and signal detection that enables the science of pharmacovigilance to grow at a rapid pace.

Drafting and submission management of PSUR, PBRER, PADER, Clinical Overview and DSURs: Comprehensive Pharmacovigilance Service packages for ROW region:

Safety reports are an essential tool in the safety evaluation throughout the life cycle of a medical product. A safety physician, a person for pharmacovigilance, a data management team, a regulatory team, and medical writers aid in the preparation of a PADER. After the first marketing authorization approval is received by a MAH, the reporting cycle starts. The first quarterly PADER needs to be presented within 30 days. PSURs are deemed important pharmacovigilance documents by the authorities, and they are subject to extreme scrutiny at the time of inspection in the EU. The regulations PSUR Pharmacovigilance are complex, and effective for multiple products. At Atop Pharma Solutions, our consultants and staff have years of experience writing periodic safety update reports, planning PADERs, and DSURs cost-effectively, whether it is a single simple DSUR or PADER or complex PSURs, we can meet the requirement.

Establishment of PSMF and drafting of Risk management plan:

We work with selected documentation systems to create and support a PSMF that accurately and exhaustively expresses your company’s PV system. A comprehensive PSMF is essential as it is a document shared with EU regulatory inspectors. The Pharmacovigilance System is designed to outline the pharmacovigilance (PV) system of the Marketing Authorization Holder (MAH). The PSMF is part of the registration dossier and should be ready within the required timelines for the Marketing Authorization Application (MAA). Our experts in Atop Pharma Solutions understand the complexness of the PSMF and follow the regulatory guidelines on Good Pharmacovigilance Practice (GVP). We guarantee that you meet all requirements in developing and maintaining your RMP. We help you set up your RMP to identify the risks of a medicinal product efficiently; it helps save your valuable time when interacting with the regulatory authorities.

Literature search -Global/local literature search and review for reports of adverse events for all types of products, using standard terms:

A systematic review that assumes only the favorable outcomes of an intervention, without considering the adverse effects can delude by a bias favoring the intervention. Systematic literature searching is identified as a critical element of the systematic review process. Readers need to be able to remember how strategic choices made in the review process decide what damages are found and how the findings may affect clinical decisions. Researchers launching a systematic review that incorporates adverse effect data should understand the grounds for the suggested methods. Atop Pharma Solutions directs you to the Population, Intervention, Comparison and Outcomes (PICO) method in a search, and you can quickly develop a progressive query to explore deeply. We help you build your risk assessment on better data from the literature and regulatory documents. We design more practical trials of historical precedents of adverse events. We also compare your drug candidate to approved drugs and monitor the post-market interpretation.

Monitoring of literature for aggregated reports and safety information:

Based on the marketing authorization status various types of reports are prepared by the MAH, which contain pre-approval aggregate safety reports and post-approval aggregate safety reports. So, Pharmacovigilance aggregate reporting is deemed a large commitment and takes considerable effort. The scientific and medical literature is an important source of data for the safety profile of medicinal products for detecting new safety signals or emerging safety issues (ESI). With Atop Pharma Solution pharmacovigilance literature review, literature critics can first levy references for ICSRs and eradicate those that are irrelevant for safety. With this workflow in place, it directs only 20-30% of the connections to product safety specialists, cutting their literature review time by 80%. As the reviews for aggregate reports and safety signals are 4-5 times pricier than ICSR reviews, the potential savings are enormous.

Scientific and medical writing: Drafting of Clinical/Non-clinical report or overview, narrative, IMPD with all regulatory compliance of EMA/any country:

To understand pharmacology, the medical writer needs to take ought to understand the entire drug development program.  Comprehending the chemistry of the drug and its mechanism of action is essential. Understanding the regulatory history allows the medical writer to contribute fully to the entire drug development program. New knowledge and data are continuously being added to the field of medicine and all such information needs to be shared with different audiences. Medical writing is the field of writing scientific papers by writers in the field of medicine and drugs. At Atop Pharma Solutions, our expert team of medical writers has an extensive research background, scientific knowledge, and experience in clinical development to yield, clear and brief manuscripts, journals, and clinical trial protocols. We have the expertise to dissect, understand critical thinking, and prepare practical scientific reports, protocols, and publications by suitable regulatory policies.