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Insights
December 19, 2024
December 19, 2024
Change of Ownership – Global Regulatory Framework
December 19, 2024
December 19, 2024
Named Patient Programme: Early Access to Unapproved Medicines
November 5, 2024
November 5, 2024
Navigating FDA Type B Meetings : Harnessing Collaboration for Success
Navigating FDA Type B Meetings: Case Study Overview APCER Life
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October 7, 2024
October 7, 2024
Collaborative Expertise Secures Successful FDA Meeting for Phase 2b Oncology Trial
Securing Type C meeting with FDA for Oncology Trial: Case
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September 13, 2024
September 13, 2024
MHRA Regulatory Connect Portal: Revolutionizing Interactions with MHRA UK
MHRA Regulatory Connect Portal: An Overview The MHRA Regulatory Connect
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September 11, 2024
September 11, 2024
Successfully Enabled CTD Modules Preparation within Stringent Timelines
Submission of Common Technical Document Modules: Case Study Overview A
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August 30, 2024
August 30, 2024
Ensuring Regulatory Compliance: Managing Global and Local Literature Surveillance for Drugs and Medical Devices for a Leading Pharmaceutical Company
Managing Global and Local Literature Surveillance: Case Study Overview Client
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July 30, 2024
July 30, 2024
Successful Project Transition Through Proactive Planning and Flawless Execution for Aggressive Go-Live for a Leading Biotech Company
With an aggressive go-live target and a need for experienced
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July 22, 2024
July 22, 2024
Ensuring Medicine Access: The Windsor Framework’s UK-Centric Solution
June 27, 2024
June 27, 2024
Re-defining Brand Value: The Role of Scientific Communication in Pharmaceutical Success
A global pharmaceutical company leveraged our Scientific Writing team’s expertise
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June 17, 2024
June 17, 2024
Risk Management Services
Identifying and managing safety concerns, implementing risk minimization measures (RMMs),
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April 30, 2024
April 30, 2024
Compiling Large Volumes of Real World Data and Creating a Report with Appendices for a Global Client
Our Medical Writing (MW) team demonstrated exceptional expertise and dedication
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April 5, 2024
April 5, 2024
Leveraging Aggregate Reporting for EU-MDR Compliance and Proactive Risk Management for a Medical Device company
A leading device manufacturer faced challenges complying with complex device
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February 19, 2024
February 19, 2024
GAP analysis and CER assessment for CE certification: A simple path to EU-MDR compliance
September 21, 2023
September 21, 2023
Ensuring EU-MDR Compliance
Medical device companies would need robust and effective strategies to
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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February 17, 2022
February 17, 2022
The EU CTR and CTIS are in effect – 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
April 26, 2021
April 26, 2021
US Medical Device Regulations
Key Regulations & Guidelines: Medical Device Reporting – 21 CFR
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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
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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
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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
APCER’s Pharmacovigilance (PV) team supported a client’s expansion into new
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March 8, 2021
March 8, 2021
Setting up Agile PV operations for a US based Pharma company
APCER’s Pharmacovigilance (PV) team helped a biotech pharmaceutical company with
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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
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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
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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
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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
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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
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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
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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
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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
…
March 8, 2021
March 8, 2021
Streamlining lifecycle management through proficient eCTD submission roadmap
APCER’s Pharmacovigilance (PV) team provided PV services right from set
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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
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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
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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
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January 13, 2021
January 13, 2021
Future Business Outlook
Mr. Tejus Menon, Executive Director shares his perspective on what
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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
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January 10, 2021
January 10, 2021
Risk minimisation measures: Tracking and effectiveness assessment
January 10, 2021
January 10, 2021
Quality Assurance services
Our team of experienced auditors help the bio-pharma companies achieve
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January 10, 2021
January 10, 2021
Medical Writing Services
Our team of efficient and experienced medical writers support the
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January 10, 2021
January 10, 2021
The Need for Vigilance
APCER Life Sciences provides the expertise and support required for
…
January 10, 2021
January 10, 2021
Post Marketing Safety Services
APCER Life Sciences provides the expertise, robust processes and infrastructure
…
January 10, 2021
January 10, 2021
Clinical Safety Services
APCER Life Sciences works together with your team and research
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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
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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
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January 6, 2021
January 6, 2021
APCER Factsheet
Snapshot of end-to-end Safety services offered by APCER Life Sciences.
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December 11, 2020
December 11, 2020
Advanced Therapy Medicinal Products – The Next Therapeutic Revolution
Dr. Vineet Kacker, Managing Director & Global Technical Head talks
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December 11, 2020
December 11, 2020
Business Continuity – 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
September 11, 2020
September 11, 2020
Personalized Therapy with Advanced Therapy Medicinal Products: A Paradigm Shift
Have any questions?
(+1) 609 455 1600
info@apcerls.com