Together for
new horizons

Specialty Areas

Safety requirements for your advanced therapy, medical device and combination products are getting more stringent. Ensuring the safety and efficacy of these products without impacting the time-to-market requires a Pharmacovigilance partner that can bring strong therapeutic and domain expertise for full life cycle management.

advanced therapy medicinal products

Advanced Therapy Medicinal Products (ATMPs) are gene, tissue or cell based therapies offering groundbreaking treatments for life-threatening or rare diseases.

medical device safety solutions

Medical devices play a key role in providing better diagnosis, screening, monitoring, rehabilitation, treatment and care of patients thereby improving the overall quality of life.

Testimonials

  • Medical Advisor, Medical Affairs,
    I must commend the organizational skill, the professionalism, the clarity, the expertise on subject matter, execution excellence that you and your team have exhibited in all of my projects where I had collaborated with you… It was a seamless, easy-going experience and I value and cherish every bit of it.
    Medical Advisor, Medical Affairs,
    A French Pharmaceutical Company
  • Global Clinical Leader, Thrombosis and Vascular Diseases,
    My experience with APCER has been excellent. Working with the team they were very helpful, knowledgeable, responsive and professional with all the work that was needed.
    Global Clinical Leader, Thrombosis and Vascular Diseases,
    A German biopharma company
  • Associate Submission Medical Writer
    APCER demonstrated extreme flexibility accommodating these changes and a number of last-minute changes that were implemented quickly and correctly. I also appreciate the flexible communication during my workday, given the time zone differences between the APCER writers and myself.
    Associate Submission Medical Writer
    A German biopharma company
  • Medical Director
    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.
    Medical Director
    US-based specialty pharmaceutical company
  • QPPV and Pharmacovigilance Head
    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.
    QPPV and Pharmacovigilance Head
  • Senior Director
    We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
    Senior Director
    US-based pharmaceutical company
  • Head, Clinical Trial Transparency
    APCER’s invaluable support with Clinical trial disclosure deadlines helped us in timely submissions of periodic reports.
    Head, Clinical Trial Transparency
    Top 10 pharmaceutical company with operations in the EU and US
  • AVP, Pharmacovigilance
    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.
    AVP, Pharmacovigilance
    US-based pharmaceutical company
  • Senior Director
    We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
    Senior Director
    US-based pharmaceutical company

How can we work together for better health?

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