Partnering with a specialised safety provider can help companies set-up cost-effective and agile PV operations in a time bound manner. View our case study on how we helped a US biopharma company setup an efficient PV system: https://bit.ly/3dpSgDE #pharmacovigilance #caseprocessing #drugsafety #pharmaceutical #regulatory #riskminimization #rems #biopharma #US
About us
APCER Life Sciences provides comprehensive drug safety/pharmacovigilance, medical information, medical writing, regulatory services, quality assurance and risk management programs to pharmaceutical and biotech companies globally. We bring medicinal / scientific expertise through our healthcare professionals & physicians and address full pharmacovigilance requirements for North America, UK & Europe markets. Our clients benefit from our vast experience in regulatory submissions across 100+ countries and consultative approach towards audit /inspection readiness. Our focus towards Patient safety and Risk profile management makes us the preferred choice for pharma companies who are looking for pre /post marketing compliance & reporting solutions. We have scalable operations across five global offices which house more than 750 employees: Princeton, NJ, USA; London, UK; Germany, Wan Chai, Hong Kong, New Delhi and Ahmedabad, India.
- Website
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http://www.apcerls.com
External link for APCER Life Sciences
- Industry
- Pharmaceutical Manufacturing
- Company size
- 501-1,000 employees
- Headquarters
- London
- Type
- Privately Held
- Founded
- 2007
- Specialties
- Clinical Safety, Pharmacovigilance, Integrated Response Center for Safety and MedInfo, Medical, Clinical, and Regulatory Writing, Hosted Safety and Medical Information Systems, EU - QPPV and PSMF Services, and 24x7, Global Outsourced Services
Locations
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Primary
Suite 211, Dowgate Hill House
14-16 Dowgate Hill,
London, EC4R 2SU, GB
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B1/F2 Mohan Cooperative Industrial Estate
Mathura Road
New Delhi, 110 044, IN
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3 Independence Way
Suite 300
Princeton, NJ 08540, US
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1601 & 1602, Wing A,
Mondeal Heights, Iscon Cross Road, SG Highway,
Ahmedabad, Gujarat 380015, IN
Employees at APCER Life Sciences
Updates
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Find out about the EU regulatory framework for PSUSA procedures, their assessment, and the timeframes for submitting variations for implementing the outcome of a PSUSA procedure in our whitepaper: https://lnkd.in/gS_WvQ5M #drugsafety #PSUSA #drugdevelopment #patientcare #riskmanagement #pharmacovigilance #pharmaceutical #pharma #apcerlifesciences #apcer
PSUSA procedures and implementation of the outcome of a PSUSA procedure - APCER Life Sciences
https://www.apcerls.com
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We are delighted to announce our association with REMS Industry Consortium (RIC) as a Silver Industry Partner, leading the way in patient-centric pharmacovigilance solutions globally! #pharmacovigilance #riskmanagement #rems #medicalinformation #regulatoryaffairs #medicalwriting #qualityassurance #drugsafety #medicaldevices #biopharma #ric
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Learn how our strong scientific evidence backed by scientific data helped one of our clients to engage with key opinion leaders and physicians to reposition one of their medicinal product effectively in the market. Download our case study now: https://bit.ly/4bqC8NG #medicalwriting #scientificwriting #scientificcommunication #diabetes #innovators #brandeddrugs #keyopinionleaders #kolengagement #KOL #regulatorycompliance #medicalwriters #pharmacovigilance #compliance #pharma #lifesciences
Re-defining Brand Value: The Role of Scientific Communication in Pharmaceutical Success - APCER Life Sciences
https://www.apcerls.com
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How partnering with a firm that specializes in regulatory, safety, and compliance can ensure Medical Device companies comply with the guidelines laid out by regulatory agencies? Learn more here: https://www.bit.ly/gmdpmsr #adverseevents #global #medicaldevice #medicaldevices #patientsafety #eumdr #postmarketsurveillance #regulatorycompliance #regulatoryaffairs #clinicaltrials #pharmacovigilance #pharma #eu #usa
Global Medical Device Post-Marketing Safety Reporting - APCER Life Sciences
https://www.apcerls.com
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The blog discusses the importance of regional collaboration among countries for safety information. It emphasizes the need for information exchange, best practices, and joint initiatives to improve pharmacovigilance. A collaborative approach facilitates a more comprehensive understanding of drug safety profiles and enables timely risks mitigation. Find out more here: https://bit.ly/bpaarl #pharmacovigilance #drugsafety #qppv #gvp #mah #psmf #europe #eu #risk #riskiminimization #riskmanagement #pharma #pharmaceutical
Pharmacovigilance Activities at Regional Level - APCER Life Sciences
https://www.apcerls.com
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Companies must submit periodic safety update reports (PSURs) and post-market surveillance reports (PMSRs) under the new EU Medical Device Regulation 2017/745 (MDR). Discover how we helped a large device company prepare 40+ high quality aggregate reports for their complex Class IIb and Class III devices within the stipulated time. Learn more: https://lnkd.in/dvX2tQXs #EUMDR #MDR #medicaldevice #pharmacovigilance #PSUR #CER #Postmarketing #AE #UADE #ADE #FDA #USFDA #medicaldevices #EUguidelines #medicaldeviceindustry #regulatoryaffairs #medicalwriting #aggregatereporting #PSMR #PSUR
Leveraging Aggregate Reporting for EU-MDR Compliance and Proactive Risk Management for a Medical Device company - APCER Life Sciences
https://www.apcerls.com
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There are many challenges facing medical device companies, including dynamic regulatory requirements, lack of expertise in preparing robust documentation, and lack of continuous monitoring. Learn about medical device regulations in our latest whitepaper to help you address these challenges: https://bit.ly/aaacac #EUMDR #MDR #medicaldevice #pharmacovigilance #PSUR #CER #Postmarketing #AE #UADE #ADE #FDA #USFDA #medicaldevices #EUguidelines #medicaldeviceindustry #regulatoryaffairs #medicalwriting
GAP analysis and CER assessment for CE certification: A simple path to EU-MDR compliance - APCER Life Sciences
https://www.apcerls.com
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Find out how REMS addresses critical safety concerns of certain medicinal products to make sure that the benefits of medicine exceed the risks. https://lnkd.in/dwS3ymMv #riskmanagment #riskmitigation #riskminimisationmeasure #rems #fda #riskbenefit #pharmacovigilance
Risk Evaluation & Mitigation Strategies: Needs, Challenges and Solutions - APCER Life Sciences
https://www.apcerls.com
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Reviewers and writers on our CMC team delivered high quality chemical and product development reports on time. To learn more, click here: https://bit.ly/cmcwriting #cmc #cmcwriting #ndafiling #fdaapproval #fda #regulatorycompliance #regulatory #regulatoryaffairs #drugsafety #pharmacovigilance #pharma #pharmaceuticals
Partnering for CMC Writing in New Drug Application - APCER Life Sciences
https://www.apcerls.com