About Us
Services
Integrated PV& MI
Pharmacovigilance
ICSR Case Processing
Literature Search
Aggregate Reporting
Signal Management
Risk Management
QPPV
PSMF
Medical Information
Integrated Response Center
Specialized REMS Contact Center
Regulatory Affairs
Medical Writing
Medical Affairs
Quality Assurance
Specialty Areas
ATMPs
Medical Devices
Insights
Brochures
Case Studies
Videos
Articles
Whitepapers
Blogs
Webinars
Infographics
News & Events
Careers
Contact Us
Services
May 3, 2023
May 3, 2023
Partnering for CMC Writing in New Drug Application
CMC writing is a standardized scientific and technical writing process
…
May 1, 2023
May 1, 2023
Risk Evaluation & Mitigation Strategies: Needs, Challenges and Solutions
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
…
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
…
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
…
August 8, 2022
August 8, 2022
Designing a Safety and Risk Management System for Cellular Therapies
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
…
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
…
December 8, 2021
December 8, 2021
Role of CAR-T therapies in haematological malignancies
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
…
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
…
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
…
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
…
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
…
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
…
March 8, 2021
March 8, 2021
Active remediation measures help mitigate major safety findings
APCER Life Sciences supported one of the biopharma companies in
…
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
…
March 8, 2021
March 8, 2021
Efficiently navigating the regulatory submission landscape
The Regulatory Affairs team at APCER Life sciences helped the
…
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
…
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
…
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
…
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
…
January 13, 2021
January 13, 2021
Future Business Outlook
Mr. Tejus Menon, Executive Director shares his perspective on what
…
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
…
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
…
January 10, 2021
January 10, 2021
Medical Writing Services
Our team of efficient and experienced medical writers support the
…
January 10, 2021
January 10, 2021
The Need for Vigilance
APCER Life Sciences provides the expertise and support required for
…
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
…
January 6, 2021
January 6, 2021
Regulatory Affairs Services
We offer end-to-end regulatory consulting and execution support services to
…
January 6, 2021
January 6, 2021
APCER Factsheet
Snapshot of end-to-end Safety services offered by APCER Life Sciences.
…
December 11, 2020
December 11, 2020
Advanced Therapy Medicinal Products – The Next Therapeutic Revolution
Dr. Vineet Kacker, Managing Director & Global Technical Head talks
…
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