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Our Values

Without any compromise of established standards, we will set and achieve targets better than competition. We will always strive for your satisfaction by building solutions around your needs in pharmacovigilance. We encourage inherent innovative skills to increase productivity and efficiency and thereby increase one’s value to the organisation and achieve superior business success...

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Our Sight on Success

With highly qualified doctors and pharmacists at the pole position and by establishing strategic partnerships with pharmaceutical companies around the world, Vigi Medsafe is determined to win the race to become a global leader in pharmacovigilance services. To enhance the awareness of and to encourage best practices in Pharmacovigilance. To achieve this goal we bring the collective experience of ...

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About Us

With highly qualified and experienced founders at the helm, Vigi Medsafe is determined to provide comprehensive services to all your Pharmacovigilance reqrements. We are dedicated, as much as you are, to keep the success of your product strong. Look ahead and reach out to us and we promise you that you will never look back....

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Drug Safety Solutions – WHY VM?

Vigi Medsafe is a comprehensive pharmacovigilance service provider with “Quality” as its main focus. The company undertakes and delivers all relevant pharmacovigilance activities that include case processing, safety document authoring etc to name a few. These services are available for molecules in development and products that are in the market. Vigi Medsafe is led by a team of highly qualified and appropriately experienced professionals with a clear understanding on the market needs and undistracted determination to provide quality services. The experts from Vigi Medsafe can consolidate clients’ global pharmacovigilance operations, will devise and develop strategies in collaboration with its clients to create a platform on which the projects can be completed on time without compromising on quality. The drug safety solutions developed by Vigi Medsafe are applicable to all pharmaceutical companies around the world whose products may be in various stages of development (clinical trials) or already in the market (post authorization) or both.

Pharmaceutical companies, clinical researchers and scientists are investing time and resources to innovate processes for developing safe and effective medicines with risks minimized and benefits maximized. The discoveries in pharmaceutical medicine over the last few years have transformed the canvas of healthcare. Like the coin has two sides, the industry has seen successes and suffered qte significantly in certain situations leading to qte a few product recalls and heavy penalties to some of the world renowned pharmaceutical companies. Pre-approval clinical studies that run through phase 1 to 3 are conducted to evaluate safety and efficacy of the medicine in development. The safety profile that develops during this transition will be included into the Investigator’s brochure (reference document for product safety) and any serious adverse event, as defined by the health authorities, that is identified new will have to be reported by the sponsor of the study to the health authorities on an expedited basis and also the information has to be passed onto all investigations sites. Timely identification of such events and alerting all stakeholders is crucial for the safety of the patient. Vigi Medsafe is highly experienced in such activities of identification of such safety events and alerting relevant stakeholders through appropriate procedures (generating SUSARs, INs etc) Even though the risk profile is fairly developed by the time authorization is granted for a particular medicinal product, there are many rare events and events that have longer latency periods that will be detected much later in the post-marketing phase. The information on risk events will be made available through periodically updated labels such as Summary of Product Characteristics (SmPC) or Prescribing Information (PI). There will be unsolicited, spontaneous reports from various sources like the healthcare professionals, lawyers, media etc. Any new event that is not mentioned in the SmPC or PI has to be reported to the health authorities on a timely manner. Vigi Medsafe has highly trained and experienced workforce to analyze such events and has delivered (reporting to health authorities and updating labels) successfully in the past.

Vigi Medsafe has developed Standard Operating Procedures (SOPs) at the time of its inception and these are the gding documents with primary focus on “Quality”. Based on these SOPs, all the reports received at Vigi Medsafe will be entered into the safety database by highly experienced associates and further the information will go through multi step qualitative and quantitative analysis not just for checking the accuracy of data but also to check for new signals (as defined by EMA or FDA) by the highly qualified MD physicians. This will help in strengthening the labels for products and thereby making better medicines available for those who need. The data that is received at Vigi Medsafe is highly confidential and hence high priority is also given to maintain confidentiality of the data. There are various controls, checks and measures in place to make sure that data is protected and secure. Even though the files will be shared amongst the employees, each and every member of Vigi Medsafe is bound by obligations of confidentiality and this is clearly outlined in employee’s contracts, company policies and SOPs. Periodical training is part of Vigi Medsafe’s procedure to maintain confidentiality. All documents outlining the procedures that govern everyday activities at Vigi Medsafe are strored in highly secure environment with access to only relevant members and readily available for audits and inspections by authorized bodies and organisations.

Drug regulators like FDA or EMA are paying close attention to drug safety as they are the approving authorities for any medicinal product to come into the market with primary intention of making sure that safe and effective medicines are available to patients. As more and more newer medicines are available for patient’s consumption and as more robust reporting and analysing systems are developed, identification and comprehensive analysis of adverse events is becoming possible for the regulators and thereby increase the scrutiny of safety profiles of both new and established products. This has increased the pressure on pharma companies to pay close attention to their own pharmacovigilance processes. Vigi Medsafe, with it highly educated staff and with focus on quality, will fulfill all reqrements of pharma companies so that they are 100% compliant with various regulations.

With post graduate qualifications in human medicine and pharmacy, with functional experience in health care industry (hospital and global pharma companies), with first hand experience working in health authorities like MHRA, with complete and up-to-date oversight on the latest developments happening in pharmaceutical world, with adequate representation in global organizations like DIA, IFPMA etc, Vigi Medsafe guarantees that the projects that it undertakes from any pharmaceutical company will be delivered on time every time with highest quality and fulfilling regulatory compliance.

Vigi Medsafe creates interest and enthusiasm in pharma companies to approach and discuss strategies that can address their pharmacovigilance needs. Once the partnership starts, Vigi Medsafe will convert this partnership into a trusted one by fulfilling the pharmacovigilance needs with focus on quality and regulatory compliance. The guidelines published by FDA, EMA, ICH etc and the internal SOPs covering all aspects of pharmacovigilance and innovative strategies will make sure that the pharma company’s needs are fulfilled without cost burden on them.

Testimonials

Complete Pharmacovigilance

Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. During recent times, the number of reports with serious adverse events arriving at various health authorities have increased exponentially and the number of deaths reported in the western world due to consumption of medicines have increased significantly. Pharmacovigilance at a global level is supervised through specialized agencies in different regions. In Europe, Pharmacovigilance is coordinated by EMA (European Medicines Agency) and the different national competent authorities, FDA in the USA, TGA in Australia, PMDA in Japan, WHO Collaborating Centre for International Drug Monitoring Uppsala, Sweden and the DCGI in India. Considering this situation, safety of a pharmaceutical product is the ethical and social responsibility of the company that produces it because risks are inherent when any medicine is consumed.

WHAT & WHY PV?

The pharma company holds the responsibility to collect the information of all events that happen in a patient who uses their product, analyse them thoroughly and scientifically to minimize the risks and maximize the benefits. The company also holds responsibility to share such information with all stakeholders through proper communication channels. This activity is resource intensive and will generally start during the drug’s research and development phase and will continue throughout its life. Effective pharmacovigilance function can often differentiate between having a drug that needs to be withdrawn from the market or let it stay in the market and survive the competition, thereby providing safer option for the patient to choose. Vigi Medsafe provides various options to the pharma companies that can be further tailored according to the needs of the pharma company.



Implementation

Drug safety - World wide view During recent times pharmacovigilance has gained lot of attention and has become center of attention even during clinical development programs due to withdrawal of many blockbuster drugs for various reasons. The regulatory authorities around the world are paying close attention to pharmacovigilance and are tightening the rules and regulations pertaining to pharmacovigilance. This has led to increased costs to the pharmaceutical companies as they had to strengthen their own pharmacovigilance processes, collect large amount of safety data, get comprehensively and scientifically analyzed before submitting such information to the health authorities. This is where Vigi Medsafe can become Pharma Company’s strategic partner to develop solutions, ensure regulatory compliance without increasing the costs, tremendously, for the concerned pharma company.