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With an impeccable track record of quality and highly ethical practices, Ahlyna serves global clients that include start-ups, mid-sized enterprises and fortune 100 companies.
Contact usProjects We Work On
Strategic Advice and set up of Pharmacovigilance
A leading Generics Company with R&D capability with several drugs in clinical development pipeline requested our team to help set up and strategise Pharmacovigilance in Europe and globally. Our team supported the company in advising on Global PV database set up including systems and processes, CTs safety support, prepare Safety management Plans for drugs in development, set up of and advise on Prescription Event Monitoring (PEM) Studies for drugs in India with KOLs; audit and inspections of all their affiliate offices globally; set up of PSUR processes and systems and authoring; developing and preparing CCDS from scratch and help prepare Safety Data Exchange Agreements (SDEAs).
See All ServicesGlobal NDA Submission for Oncology Product
A MNC requested us to help in the entire PV management and work for global NDA submission of novel Oncology product to FDA, EMA and PMDA. We managed the entire project including assessment, analysis of various data from several Phase II and III clinical trials, DSMB data review, assessment and responding to DSMB, reviewing and authoring of several important documents including Integrated Safety Summary (ISS); Clinical Study Reports; Patient narratives and safety narratives, DDPS etc. Our team also prepared from scratch the Risk Management Plans, EU SmPC, US PI and other safety documents for eCTD submissions globally. This project was completed by our team in 12 months time and well before global submissions that enabled the sponsor company to submit MAA to all the three regulatory agencies FDA, EMA and PMDA before the actual date of submission.
See All ServicesGood PSUR Practice and Quality Review of PSURs
A MNC requested our team to help them with setting up and strategise a Good PSUR Practice process, as they had received several assessment reports from various regulatory agencies regarding the low quality standard of its PSUR which was one of the triggers for an inspection. Our team helped the company by spending over four weeks in understanding the current set up and then entirely changed the process and gave training in writing a PSUR including understanding the content and developing a new PSUR template as per EU regulations. Our team also helped the sponsor company to set up a pilot project for the PSURs and in strategising which PSUR should be done in house and which outsourced. With the implementation of this new process and setting up of the Good PSUR Practice, regulatory authorities have sent positive feedback and assessment reports to the sponsor.
See All ServicesSignal Detection and Issue Work Up
A MNC requested our team for urgent help to review and close over more than 7000 PT terms each of the Signals for their Transplant and Oncology portfolio group of drugs. This project included detailed analysis of the events and Issue Work Up of these signals identified through Quantitative Signal Detection and Management Tool and then authoring of several Safety Reports for the signals that were generated for submission to the Regulatory Authorities. This project helped the sponsors to get on top of the signals for these therapeutic areas and close all the signals.
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Urgent Safety Issue requiring DHCP Letter
A MNC requested our team to help with an Urgent Analysis and Comprehensive report authoring of a Specific Urgent Safety Issue that had to be submitted to EMA as part of CHMP request. Our team executed the project by doing a detailed analysis of all the events involved for this specific issue, wrote the entire report consisting of more than 200 pages and also authored the Dear HCP letter for submission to the Regulatory Authority.
See All ServicesPre-inspection Assessment of Pharmacovigilance Systems
A MNC requested a comprehensive assessment of both the pre and post marketing activities in its European headquarters and UK and Irish affiliates, and also requested help and expert advice in the preparation of upcoming MHRA Inspection. Contacted our team for under taking Mock Inspection, as PV experts for QPPV Inspection, Inspection for Global Central Operations and Affiliate Pharmacovigilance Inspection. The assessment was conducted over a three-week period by an experienced pharmacovigilance expert and QPPV. The experienced pharmacovigilance expert ensured that the assessment identified key gaps in pharmacovigilance systems, and that pragmatic and effective recommendations for improvements were made. The company received the assessment report very positively and implemented corrective actions before the inspection. For those corrective actions that required a longer implementation period, a plan of action was prepared which was acceptable to the regulatory inspectors. As a result of the assessment, pharmacovigilance personnel were well prepared for the subsequent inspection, which progressed smoothly with very few findings
See All ServicesMHRA PV Inspections
A MNC requested our team for help with their forthcoming MHRA Inspections in PV after receiving several critical findings in previous inspections from various competent authorities. Our team helped them by changing and implementing several processes and handled the inspections professionally which resulted in positive comments by the inspectors and less significant findings.
See All ServicesDevelopment and Preparation of SDEAs
A MNC requested our team for help with developing and preparing of several SDEAs for various products as part of the commitment following several inspections. Our team helped the company in preparing these legal documents interacting with pharmacovigilance department, legal department and various other license partners.
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