Services

April 5, 2021

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

March 9, 2021

A Quick Guide to Referencing an Approved Product for ANDA

Introduction A generic drug manufacturer refers to a reference listed drug (RLD) (an approved listed
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 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

Strengthening QPPV oversight through expert PSMF management for a global pharmaceutical company

APCER helped a leading generics company to streamline its PV related processes within 30 days.
March 8, 2021

Established a unifed, 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

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

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

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 8, 2021

Top 20 Pharmaceutical Innovator Raises Standards and Reduces Costs with Support from APCER Life Sciences

APCER Life Sciences as a specialized PV partner helped the company to harmonize all its
March 8, 2021

Growing Generics Company Teams with APCER Life Sciences to File Marketing Authorization Applications without Delay

Our team of Regulatory experts helped a generic pharma company seek approval in the UK
March 8, 2021

Innovative Biotechnology Company Relies on APCER Life Sciences to Manage Complex Safety Reporting in Oncology Trials

APCER Life Sciences supported an innovative biotechnology company in managing complex pharmacovigilance and regulatory requirements
February 18, 2021

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

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

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 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 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

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