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Insights
September 21, 2023
September 21, 2023
Ensuring EU-MDR Compliance
Medical device companies would need robust and effective strategies to comply with the ever-changing regulatory
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September 7, 2023
September 7, 2023
Pharmacovigilance Activities at Regional Level
May 3, 2023
May 3, 2023
Partnering for CMC Writing in New Drug Application
CMC writing is a standardized scientific and technical writing process to develop the documentation needed
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May 1, 2023
May 1, 2023
Risk Evaluation & Mitigation Strategies: Needs, Challenges and Solutions
March 7, 2023
March 7, 2023
PSUSA procedures and implementation of the outcome of a PSUSA procedure
March 6, 2023
March 6, 2023
Establishing a regulatory roadmap for post-approval lifecycle management
A drug product transitions from different phases throughout its life cycle. The sponsors/applicants may outsource
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February 22, 2023
February 22, 2023
Implementing DMAIC Tool of Lean Six Sigma in PV Risk Management Activities Leveraging Automation
December 6, 2022
December 6, 2022
Global Medical Device Post-Marketing Safety Reporting
With the ever-growing knowledge of science and application of advanced technology, new and sophisticated medical
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September 30, 2022
September 30, 2022
Managing seamless transition and establishing KPI driven operations
Managing Medical information (MI) services in-house is a major challenge for any pharmaceutical company. Read
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September 22, 2022
September 22, 2022
Patient Safety as a part of Clinical Development Strategy for CGTs/ATMPs
September 2, 2022
September 2, 2022
Updating a complex Investigator Brochure (IB) for an oncology product within demanding timelines
Our Medical Writing team helped the client in updating and submitting high-quality investigator brochure- a
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August 8, 2022
August 8, 2022
Designing a Safety and Risk Management System for Cellular Therapies
August 5, 2022
August 5, 2022
3 Key Success Factors to help with your Request for Proposal (RFP) process
Ms. Shellie Cholke, Vice President – Sales talks about three key success factors to help
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June 20, 2022
June 20, 2022
Clinical and Post-marketing Safety Services
APCER Life Sciences provides the right expertise and support required for coping up the ever-dynamic
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June 16, 2022
June 16, 2022
Business Priorities in a Drug life cycle
June 16, 2022
June 16, 2022
Model for Technology-enabled Integrated Pharmacovigilance Services
June 16, 2022
June 16, 2022
Choice of compliant safety databases
June 16, 2022
June 16, 2022
Key automation elements within safety platform
June 16, 2022
June 16, 2022
Benefits of Integrated Pharmacovigilance
June 16, 2022
June 16, 2022
Technology Enabled Integrated Pharmacovigilance Services
Our Integrated Pharmacovigilance operating model offers choice of best-in-class databases coupled with in-house scientific expertise
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June 1, 2022
June 1, 2022
In Vitro Medical Devices Regulation (IVDR) – Regulatory Framework
May 18, 2022
May 18, 2022
Standardization and publication of evidence-based local recommendations for pharmacological treatment of pain
We supported a large biopharma company in preparing manuscript/narrative review articles and leveraged our Medical
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April 21, 2022
April 21, 2022
Scaling up to address safety challenges for an Oncology product
APCER life sciences through its oncology expertise helped the pharma company manage its pharmacovigilance activites
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February 17, 2022
February 17, 2022
The EU CTR and CTIS are in effect β Are you ready?
December 8, 2021
December 8, 2021
Role of CAR-T therapies in haematological malignancies
August 13, 2021
August 13, 2021
Outsourcing Pharmacovigilance: Benefits of a Specialized Safety Partner
August 2, 2021
August 2, 2021
Management of COVID-19
April 26, 2021
April 26, 2021
US Medical Device Regulations
Key Regulations & Guidelines: Medical Device Reporting – 21 CFR Part 803 Guidance on Medical
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April 26, 2021
April 26, 2021
EU Medical Device Regulations
April 26, 2021
April 26, 2021
Post-Brexit Medical Device Regulations
April 26, 2021
April 26, 2021
Safety & Regulatory requirements for Medical Devices
April 26, 2021
April 26, 2021
Technological Advancements in Medical Devices
April 23, 2021
April 23, 2021
Regulatory Services in the European Union
Rapidly changing regulations in the European Union are making regulatory compliance even more stringent. As
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April 23, 2021
April 23, 2021
Pharmacovigilance Services in the European Union
The EU and UK regions have stringent Pharmacovigilance and regulatory requirements such as electronic and
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April 23, 2021
April 23, 2021
COVID-19 vaccine strategies: Are we immune to emerging variants?
April 5, 2021
April 5, 2021
Regulatory considerations for cellular and gene therapy products in EU and US: A comparative analysis
March 9, 2021
March 9, 2021
Classification of cellular therapy and gene therapy (CGT) products: How regulators are working with industry
March 9, 2021
March 9, 2021
A Quick Guide to Referencing an Approved Product for ANDA
March 8, 2021
March 8, 2021
End-to-end pharmacovigilance support for a UK-based pharmaceutical company
APCERβs Pharmacovigilance (PV) team supported a clientβs expansion into new markets by setting up a
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March 8, 2021
March 8, 2021
Setting up Agile PV operations for a US based Pharma company
APCERβs Pharmacovigilance (PV) team helped a biotech pharmaceutical company with set up, training and database
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March 8, 2021
March 8, 2021
Final Guidance on Competitive Generics Therapy (CGT): Opportunity to benefit from 180-day market exclusivity
March 8, 2021
March 8, 2021
Enabling compliance through strong PSMF management & QPPV oversight
APCER helped a leading generics company to streamline its PV related processes within 30 days.
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March 8, 2021
March 8, 2021
Established a unified, global PV system for a pharma company after multiple M&A
We helped a large pharmaceutical company successfully transition its pharmacovigilance (PV) processes and helped establish
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March 8, 2021
March 8, 2021
Accelerating product approval by handling complex and voluminous medical writing projects
Our Medical Writing team helped the client in handling e-submission ready documents and accelerated the
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March 8, 2021
March 8, 2021
Enabling global expansion by establishing an integrated PV system
APCER helped a global pharmaceutical company in establishing a collaborative global pharmacovigilance (PV) governance model;
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March 8, 2021
March 8, 2021
Active remediation measures help mitigate major safety findings
APCER Life Sciences supported one of the biopharma companies in assessing the effectiveness and setting
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March 8, 2021
March 8, 2021
Efficient Risk Management Support for Marketing Authorization Applications in LATAM Region for a Leading Pharma Company
APCER Life Sciences supported a leading generic pharma company with managing the EU RMP requirements
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March 8, 2021
March 8, 2021
Efficiently navigating the regulatory submission landscape
The Regulatory Affairs team at APCER Life sciences helped the client with streamlining the XEVMPD
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March 8, 2021
March 8, 2021
Inspection Readiness: Supporting the pharma company in ensuring regulatory compliance with highest standards
Read how our Quality Assurance team helped a pharma company successfully host the USFDA inspection
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March 8, 2021
March 8, 2021
Streamlining lifecycle management through proficient eCTD submission roadmap
APCERβs Pharmacovigilance (PV) team provided PV services right from set up, training and database usage.
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March 8, 2021
March 8, 2021
GCP Audits in EU requiring local language competency for a biopharma company
We helped a biopharma company to set up end-to-end Quality Management System (QMS) and successfully
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March 8, 2021
March 8, 2021
Significance of Medical Monitoring in smooth progression of clinical trials
APCER Life Sciences helped develop the strategy and provided medical monitoring services that accelerated the
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March 8, 2021
March 8, 2021
Bridging the gaps and inconsistencies within CT program through an expert overlay of medical monitors
Our medical monitoring team with experience and expertise in early clinical development stages provided oversight
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March 5, 2021
March 5, 2021
Emerging COVID-19 variants:
Potential barriers to Mass Vaccination
January 13, 2021
January 13, 2021
Future Business Outlook
Mr. Tejus Menon, Executive Director shares his perspective on what will companies do in the
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January 12, 2021
January 12, 2021
Importance of Engaging a Safety Partner Early in the Drug Life Cycle
Ms. Jeanne Schow, Vice President & US Head of Business Development talks the key benefits
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January 10, 2021
January 10, 2021
Risk minimisation measures: Tracking and effectiveness assessment
January 10, 2021
January 10, 2021
Virtual Auditing Services
Our team of experienced auditors help the bio-pharma companies achieve process excellence and regulatory compliance.
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January 10, 2021
January 10, 2021
Medical Writing Services
Our team of efficient and experienced medical writers support the biopharma companies in delivering high
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January 10, 2021
January 10, 2021
The Need for Vigilance
APCER Life Sciences provides the expertise and support required for coping up the ever-dynamic global
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January 10, 2021
January 10, 2021
Post Marketing Safety Services
APCER Life Sciences provides the expertise, robust processes and infrastructure required for global pharmacovigilance. Our
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January 10, 2021
January 10, 2021
Clinical Safety Services
APCER Life Sciences works together with your team and research partners to create a centralized
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January 10, 2021
January 10, 2021
Major safety challenges faced by ATMP companies
January 10, 2021
January 10, 2021
Novelty of Advanced therapy medicinal products
January 8, 2021
January 8, 2021
Pharmaceutical Product Lifecycle Management: A Regulatory Consideration
January 6, 2021
January 6, 2021
RMP Team Collaboration Across Functions
January 6, 2021
January 6, 2021
aRMM Implementation Strategy
January 6, 2021
January 6, 2021
Identification of risks and determination of aRRM requirement
January 6, 2021
January 6, 2021
Medical Information Services
APCER Life Sciences provides 24×7 fully customizable, multi-channel and multi-lingual Medical Information services to biopharma
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January 6, 2021
January 6, 2021
Regulatory Affairs Services
We offer end-to-end regulatory consulting and execution support services to bio-pharma companies to meet the
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January 6, 2021
January 6, 2021
APCER Factsheet
Snapshot of end-to-end Safety services offered by APCER Life Sciences. We provide comprehensive drug safety/pharmacovigilance,
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December 24, 2020
December 24, 2020
Need for successful launch of Mass Vaccination: Is the world ready?
December 11, 2020
December 11, 2020
Advanced Therapy Medicinal Products β The Next Therapeutic Revolution
Dr. Vineet Kacker, Managing Director & Global Technical Head talks about the how Advanced Therapy
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December 11, 2020
December 11, 2020
APCERβs Response to COVID-19
December 11, 2020
December 11, 2020
Business Continuity β An Agile Approach
November 5, 2020
November 5, 2020
Human medicinal products containing nitrosamine impurities: Regulatory landscape in the United States and the European Union
October 1, 2020
October 1, 2020
Vaccine Strategies for COVID-19
September 11, 2020
September 11, 2020
Personalized Therapy with Advanced Therapy Medicinal Products: A Paradigm Shift
June 10, 2020
June 10, 2020
The Coronavirus Pandemic β A Scientific Review of the Current State of Knowledge
June 1, 2020
June 1, 2020
Role of Cellular Therapies in COVID-19 Management
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