Safety is an essential ingredient of any clinical studies. Pharmacovigilance is like a sunshade to represent activity for continuous monitoring and evaluating side effects related with medicines.
It is a key component of effective drug regulation systems, public health programmes and clinical practice.
We believe in continuous regulatory compliance through procedure excellence and an reliable assurance to Quality.
We offer inclusive associate pharmacovigilance consulting services transversely globe to our valued clients from Case Intake to Safety Risk Management through regulatory compliance, higher efficiency and deliberate drug safety consequences.
We leverage our field knowledge and widespread industrial knowledge to provide “One-stop” Pharmacovigilance facilities:
Team covers vastly knowledge safety and regulatory professionals as well as medical experts transversely globe involved in providing high-quality PV, regulatory and QPPV facilities to our industry leading clients.
In order to complete on-time, efficient implementation, our global safety team coordinates efforts with market leading clients, identifying and anticipating their pharmacovigilance needs.
An wide-ranging global network of partners and important judgement leaders is one of our key properties. our expert teams in operations, technology and accessing support whole pharmacovigilance journey, from proof-of-concept to end-to-end services.
We have cleared examinations by various Regulatory figures without any monitoring is the conclusion of our experience, knowledge, commitment and distinction in serving our clients global by providing benchmark level services.
Demonstrated capability to development high case volumes and be able to volume fluctuations.
Adverse event (AE) reporting involves the receipt, triage, data entry, assessment, distribution, reporting (if appropriate), and archiving of AE data and documentation.
Health regulatory authorities (RAs) are escalate safety regulations and attention on Literature Monitoring in all countries. It is precisely stated that this applies whether the product is marketed or not. Therefore, it is experted of MAH to keep track to potential publication through a detailed literature review of globally used reference database.
Published scientific and medical literature is a important basis of data for monitoring safety profile and risk benefit balance of medicinal and biological products as well as medical devices, particularly in relative to the recognition of new safety signal or emerging safety issues.
In pharmacovigilance, case processing is the essential activity that delivers data for the investigation of adverse effects that allows to notice new safety concerns and to intermittently evaluate the benefit to risk ratio related with the use of a pharmaceutical product. In order to ensure accurate analysis and take remedial step which in turn helps to protect patient health and allow safe drug use, processing safety data with precision and quality is essential. The majority of regulatory agencies require a safety services document called an individual case safety reports (ICSR), which cotains the information needed to report adverse events, product related issues, and consumer complains regarding any drug products.
The PSMF is a permitted obligation in the many regulated agencies. The PSMF shall designate comprehensive explanation of pharmacovigilance system for the organization and provision/document its agreement with Good Pharmacovigilance Practices (GVP) requirements.
The pharmacovigilance system is described in the PSMF, which national competent authorities may request and evaluate during marketing authorization application or post authorization/regulatory inspection and audit. From time to time, It is compulsory for any MAH (Manufacturing Authorization Holder) to improve all Essential elements of PSMF accompanied by all the information in the Annexures (A to I).
Safety Data Exchange Agreements (SDEA) are legally binding contracts that guarantee all safety information about licensed product will be delivered promptly and reliably to the marketing authorization holder (MAH) so that they may achieve their legal commitment to collective safety data and to submit safety reports in a timely manner.
All the companies must have safety data exchange agreements in place in order to remain in full regulatory compliance.
A Qualified all of its pharmacovigilance duty and that ultimately the safety of Person and a deputy QPPV is permitted requirement when any Marketing Authorization Holder (MAH) has acceptance to market a product in the EU/EEA. QPPV must be “appropriately qualified and to have recognized knowledge in all features of pharmacovigilance.” A QPPV has a dominant character attentive on guaranteeing the company is meeting the public using medicine is enlarge.
Choosing the right QPPV, is dynamic in supplementary your company influence its pharmacovigilance objectives as experienced QPPV helps in providing cost-effective solutions for filing regulatory complaints about established pharmacovigilance systems. Our QPPVs are extremely skilled and has excessive knowledge in establishing and maintaining Pharmacovigilance system regulatory complaint.
We provide an extensive network of EU local representatives or pharmacovigilance officers (NPRP – also known as local QPPV or local contact persons). These are the primary contacts for local competent authorities and work closely with EEAQPPV. It also assists in understanding the requirements of local representatives / NPRPs of relevant EU member states.
Pharmacovigilance and risk management are important in the development and commercialization of medication and cover many highly regulatory activity around the world signal management can be used not only in clinical development but also in the post marketing stages of the product life cycles.
Our team has deep expertise in all signal management activities, including detection, verification, prioritization and evaluation. The team conducts a cumulative review of the data using a variety of sources e.g. Safety data from spontaneous cases, clinical trials and non-intervention studies, and literature reviews to identify and assess potential new signals. We also have sufficient training and experience in using the EudraVigilance data analysis system. It is functional and ensures that the certificate holder (MAH) meets the requirements for signal detection and management.
Our procedures for signal detection and management are written in accordance to GVP Module IX. We shall make available you with Signal Detection report to estimate effect on benefit-risk profile.
A product is contemplate to be “safe” if it has an suitable benefit-risk balance for conscious population and use. Risk management is the regulation within pharmacovigilance that is accountable for signal detection and the monitoring of the risk-benefit contour of medicines.
A Risk Management plan (RMP) is a detailed and complex document that reflects current knowledge about safety and effectiveness of a drug risk mitigation measures are described in the risk management plan (RMP) for a particular product. Marketing authorization holders are required to obtain an RMP for any new medicinal products intended for human use. For nationally licensed products an RMP must be submitted to the HPRA for review and approval
Our pharmacovigilance (PV) professionals in organisation with our non-clinical, clinical and quality teams directors you through the method of developing and maintaining a quality RMP that encounters all regulatory supplies. Our service includes:
