About Us
Services
Pharmacovigilance
ICSR Case Processing
Literature Search
Aggregate Reporting
Signal Management
Risk Management
QPPV
PSMF
Medical Information
Regulatory Affairs
Medical Writing
Medical Affairs
Specialty Areas
ATMPs
Medical Devices
Insights
Brochures
Case Studies
Videos
Articles
Whitepapers
Blogs
Webinar Recordings
Infographics
News & Events
Careers
Contact Us
Case Studies
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
…
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
…
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
…
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
…
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
…
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
…
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 markets by setting up a
…
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 set up, training and database
…
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.
…
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
…
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
…
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;
…
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
…
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
…
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
…
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
…
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 up, training and database usage.
…
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
…
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
…
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
…
Have any questions?
(+1) 609 455 1600
info@apcerls.com