Developing and marketing medical products requires a constant output of high quality scientific writing. APCER Life Sciences has an experienced team of writers with clinical, medical, and regulatory expertise to help companies document efficacy and safety and stay in compliance worldwide throughout the product lifecycle. With strengths in project governance and information technology, APCER develops and executes integrated processes that facilitate the transfer of data and knowledge. All content is either written by or written under the close supervision of a physician, always.
APCER has extensive experience in signal detection and benefit-risk analysis. Our teams perform regular signal analyses and can create the complete report or sections of the Periodic Benefit-Risk Evaluation Report (PBRER), Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Summary Bridging Reports (SBRs), PSUR Addendum Reports (ARs), and Development Safety Update Reports (DSURs).
APCER’s speed, responsiveness and flexibility to meet our safety needs is something we have always valued. APCER has helped harmonize our global pharmacovigilance operations and made us compliant with ever changing regulations.
The audit was carried out professionally and objectively. The scope of the audit was relevant and appropriate, and time efficient. The discussions during the audit were constructive and recommendations where helpful and appropriate. The team members involved in the audit had a positive experience and were made to feel at ease by the auditors.
We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
APCER’s invaluable support with Clinical trial disclosure deadlines helped us in timely submissions of periodic reports.
We appreciate APCER for its efficiency in responding to matters that they get even at the eleventh hour. Working with APCER has made compliance a lot easier.
We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.