APCER Life Sciences

Information

APCER Life Sciences, an ISO 9001:2015, ISO 27001:2022 and ISO 27701:2019 certified company, provides comprehensive drug safety/pharmacovigilance, medical information, medical writing, regulatory services, quality assurance and risk management programs to pharmaceutical and biotech companies globally.

Our clients benefit from our vast experience in regulatory submissions across 100+ countries, consultative approach towards audit /inspection readiness and scientific support towards various therapeutic areas.

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.

APCER’s customers are pharma and biotech companies who develop and commercialize products including biologics, vaccines, devices, consumer healthcare, combination products and cell & gene therapies.


Products and Services
Adverse Event Management/SoftwareConsultingDrug Safety / PharmacovigilanceMedical Affairs and Scientific CommunicationsMedical Devices/Combination ProductsMedical InformationMedical WritingPatient ComplianceRegulatory Document PreparationRisk-Based Monitoring
Booth Giveaways
Apple Watch Series 9
Job Postings
https://www.apcerls.com/careers/

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Contact details

+1 609 455 1600
marketing@apcerls.com
https://www.apcerls.com/
111 Town Square Place
Suite 860, 07310, Jersey City, New Jersey, United States

Documents & Links

APCER FactsheetAPCER Life Sciences provides 24×7 fully customizable, multi-channel and multi-lingual Medical Information services to biopharma companies.
Clinical and Post-marketing Safety ServicesAPCER Life Sciences provides the right expertise and support required for coping up the ever-dynamic global regulatory requirements.
Technology Enabled Integrated Pharmacovigilance ServicesOur Integrated Pharmacovigilance operating model offers choice of best-in-class databases coupled with in-house scientific expertise to deliver high-quality com
Medical Information ServicesAPCER Life Sciences provides 24×7 fully customizable, multi-channel and multi-lingual Medical Information services to biopharma companies.
Enabling global expansion by establishing an integrated PV systemWe helped a global pharmaceutical company in establishing a collaborative global pharmacovigilance governance model; setting up a single safety database
Managing Seamless Transition and Establishing KPI driven OperationsManaging MI services inhouse is a major challenge for any pharmaceutical company We supported a global biopharma company in managing seamless transition
Enabling compliance through strong PSMF management & QPPV oversightWe helped a leading generics company to streamline its PV related processes within 30 days and established under EU QPPV oversight and ensured harmonization
Establishing a regulatory roadmap for post-approval lifecycle managementOur regulatory team supported one of the global Biopharma company in timely submitting eCTD dossiers in different geographies, managed hassle-free transition
Leveraging Aggregate Reporting for EU-MDR Compliance and Risk ManagementOur team of experts helped the company establish a robust process for preparing and delivering complex, high-volume reports in a timely and compliant manner

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