February 19, 2024

GAP analysis and CER assessment for CE certification: A simple path to EU-MDR compliance

January 11, 2024

Performing gap analysis and CER assessment for CE marking
by achieving compliance with EU-MDR

September 21, 2023

Ensuring EU-MDR Compliance

Medical device companies would need robust and effective strategies to comply with the ever-changing regulatory
September 7, 2023

Pharmacovigilance Activities at Regional Level

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
May 1, 2023

Risk Evaluation & Mitigation Strategies: Needs, Challenges and Solutions

March 7, 2023

PSUSA procedures and implementation of the outcome of a PSUSA procedure

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
February 22, 2023

Implementing DMAIC Tool of Lean Six Sigma in PV Risk Management Activities Leveraging Automation

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
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
September 22, 2022

Patient Safety as a part of Clinical Development Strategy for CGTs/ATMPs

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
August 8, 2022
pharmacovigilance service providers in uk

Designing a Safety and Risk Management System for Cellular Therapies

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
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
June 16, 2022

Business Priorities in a Drug life cycle

June 16, 2022

Model for Technology-enabled Integrated Pharmacovigilance Services

June 16, 2022

Choice of compliant safety databases

June 16, 2022

Key automation elements within safety platform

June 16, 2022

Benefits of Integrated Pharmacovigilance

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
June 1, 2022

In Vitro Medical Devices Regulation (IVDR) – Regulatory Framework

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
April 21, 2022
pharmacovigilance services

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
February 17, 2022

The EU CTR and CTIS are in effect – Are you ready?

December 8, 2021

Role of CAR-T therapies in haematological malignancies

August 13, 2021

Outsourcing Pharmacovigilance: Benefits of a Specialized Safety Partner

August 2, 2021

Management of COVID-19

April 26, 2021

US Medical Device Regulations

Key Regulations & Guidelines: Medical Device Reporting – 21 CFR Part 803 Guidance on Medical
April 26, 2021

EU Medical Device Regulations

April 26, 2021

Post-Brexit Medical Device Regulations

April 26, 2021

Safety & Regulatory requirements for Medical Devices

April 26, 2021

Technological Advancements in Medical Devices

April 23, 2021

Regulatory Services in the European Union

Rapidly changing regulations in the European Union are making regulatory compliance even more stringent. As
April 23, 2021

Pharmacovigilance Services in the European Union

The EU and UK regions have stringent Pharmacovigilance and regulatory requirements such as electronic and
April 23, 2021

COVID-19 vaccine strategies: Are we immune to emerging variants?

April 5, 2021

Regulatory considerations for cellular and gene therapy products in EU and US: A comparative analysis

March 9, 2021

Classification of cellular therapy and gene therapy (CGT) products: How regulators are working with industry

March 9, 2021

A Quick Guide to Referencing an Approved Product for ANDA

March 8, 2021
pharmacovigilance consulting services

End-to-end pharmacovigilance support for a UK-based pharmaceutical company

APCER’s Pharmacovigilance (PV) team supported a client’s expansion into new markets by setting up a
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 set up, training and database
March 8, 2021

Final Guidance on Competitive Generics Therapy (CGT): Opportunity to benefit from 180-day market exclusivity

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.
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
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
March 8, 2021
end to end pharmacovigilance

Enabling global expansion by establishing an integrated PV system

APCER helped a global pharmaceutical company in establishing a collaborative global pharmacovigilance (PV) governance model;
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
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
March 8, 2021

Efficiently navigating the regulatory submission landscape

The Regulatory Affairs team at APCER Life sciences helped the client with streamlining the XEVMPD
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
March 8, 2021

Streamlining lifecycle management through proficient eCTD submission roadmap

APCER’s Pharmacovigilance (PV) team provided PV services right from set up, training and database usage.
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
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
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
March 5, 2021

Emerging COVID-19 variants:
Potential barriers to Mass Vaccination

January 13, 2021

Future Business Outlook

Mr. Tejus Menon, Executive Director shares his perspective on what will companies do in the
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
January 10, 2021

Risk minimisation measures: Tracking and effectiveness assessment

January 10, 2021

Virtual Auditing Services

Our team of experienced auditors help the bio-pharma companies achieve process excellence and regulatory compliance.
January 10, 2021

Medical Writing Services

Our team of efficient and experienced medical writers support the biopharma companies in delivering high
January 10, 2021

The Need for Vigilance

APCER Life Sciences provides the expertise and support required for coping up the ever-dynamic global
January 10, 2021

Post Marketing Safety Services

APCER Life Sciences provides the expertise, robust processes and infrastructure required for global pharmacovigilance. Our
January 10, 2021

Clinical Safety Services

APCER Life Sciences works together with your team and research partners to create a centralized
January 10, 2021

Major safety challenges faced by ATMP companies

January 10, 2021

Novelty of Advanced therapy medicinal products

January 8, 2021

Pharmaceutical Product Lifecycle Management: A Regulatory Consideration

January 6, 2021

RMP Team Collaboration Across Functions

January 6, 2021

aRMM Implementation Strategy

January 6, 2021

Identification of risks and determination of aRRM requirement

January 6, 2021

Medical Information Services

APCER Life Sciences provides 24×7 fully customizable, multi-channel and multi-lingual Medical Information services to biopharma
January 6, 2021

Regulatory Affairs Services

We offer end-to-end regulatory consulting and execution support services to bio-pharma companies to meet the
January 6, 2021

APCER Factsheet

Snapshot of end-to-end Safety services offered by APCER Life Sciences. We provide comprehensive drug safety/pharmacovigilance,
December 24, 2020

Need for successful launch of Mass Vaccination: Is the world ready?

December 11, 2020

Advanced Therapy Medicinal Products – The Next Therapeutic Revolution

Dr. Vineet Kacker, Managing Director & Global Technical Head talks about the how Advanced Therapy
December 11, 2020
pharmacovigilance companies in usa

APCER’s Response to COVID-19

December 11, 2020

Business Continuity – An Agile Approach

November 5, 2020

Human medicinal products containing nitrosamine impurities: Regulatory landscape in the United States and the European Union

October 1, 2020

Vaccine Strategies for COVID-19

September 11, 2020

Personalized Therapy with Advanced Therapy Medicinal Products: A Paradigm Shift

June 10, 2020

The Coronavirus Pandemic – A Scientific Review of the Current State of Knowledge

June 1, 2020

Role of Cellular Therapies in COVID-19 Management