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December 2, 2020

Together for regulatory compliance

Regulatory Affairs

APCER’s Regulatory team support their clients in entire lifecycle of drug Product in all major markets – US, Canada, EU and UK. We provide strategy, prepare & compile all kind of submissions in the development phase, marketing authorization phase and Life Cycle Management. Our Regulatory Affairs team helps clients with product selection, filing strategy, and approach, performing all the necessary regulatory activities throughout the lifespan of a product. We have Regulatory CMC expertise and work together with our Regulatory Medical Writers to address review and writing requirements of our clients for their high quality submissions.

Regulatory Strategy

APCER works together with clients on the strategic planning of regulatory submissions with US and European Authorities.

Regulatory Intelligence

APCER tracks regulatory changes around the globe and provides updates applicable to your company’s product applications.

Approval Lifecycle Management

APCER supports filing of documents throughout the product lifecycle, from the IND, NDA, ANDA, CTD and eCTD, to Clinical Overviews, annual reports and periodic reports.

Submissions

APCER provide submission services to regulators and Competent Authorities worldwide, electronically wherever possible, through hosted production and document management systems.

Product Labeling Maintenance

Based on post-marketing safety experience, APCER prepares and submits updates to the Summary of Product Characteristics (SmPC), patient information leaflets, and product labeling.

Responses to Health Authorities

APCER prepares and manages a complete response to questions received from Health Authorities, particularly those related to product safety that may arise from PSURs and other reports submitted.

Together to stay in compliance

APCER builds customized regulatory solutions with an understanding of the size of the organization, the number of products and marketing authorizations, case load, therapeutic class, and other relevant parameters to ensure a client is always in compliance and the process remains cost effective. We work together as the regulatory compliance expertise on your team of research and development, manufacturing, and quality organizations, or serve as the liaison with regulatory agencies on your behalf.

Download Regulatory Affairs Brochure

The APCER Advantage

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Domain Expertise
  • 100+ physicians, 90% healthcare professionals supporting drug safety and Pharmacovigilance
  • Experience and expertise in different product types including Drugs, Vaccines, Biologics, Biosimilars, Cell and Gene Therapy products / Advanced Therapy Medicinal Products, Medical Devices, and Combination products
  • Medical and scientific writing to support global product approval and post marketing requirements
pharmacovigilance services
Client Focus
  • Scalable and flexible operating models
  • Strong governance with collaborative approach
  • Outcome-driven engagements
  • End-to-end Pharmacovigilance, Medical Information, Regulatory Affairs, Quality Assurance and Medical Writing activities throughout the Product lifecycle
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Global Presence
  • Presence in US, UK, Europe, and Asia
  • Safety reporting capabilities in 100+ countries
  • Medical Information coverage in 50+ countries and 30+ languages, scalable to 100+ languages
  • Developing and contributing to regulatory strategies, to maintain global regulatory compliance across the product life cycle
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Quality and Compliance
  • Extensive experience in supporting successful Regulatory Inspections
  • ISO accreditations received:
    ISO 9001:2015 (QMS)
    ISO 27001:2013 (ISMS)
    ISO 27701:2019 (PIMS)

Explore More

  • March 9, 2021

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


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  • March 9, 2021

    A Quick Guide to Referencing an Approved Product for ANDA


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  • March 8, 2021

    Final Guidance on Competitive Generics Therapy (CGT): Opportunity to benefit from 180-day market exclusivity


    View more
  • March 8, 2021

    Enabling compliance through strong PSMF management & QPPV oversight


    View more
  • March 8, 2021

    Accelerating product approval by handling complex and voluminous medical writing projects


    View more
  • March 8, 2021

    Efficiently navigating the regulatory submission landscape


    View more
  • March 8, 2021

    Inspection Readiness: Supporting the pharma company in ensuring regulatory compliance with highest standards


    View more
  • March 8, 2021

    Streamlining lifecycle management through proficient eCTD submission roadmap


    View more
  • March 8, 2021

    GCP Audits in EU requiring local language competency for a biopharma company


    View more
  • January 12, 2021

    Importance of Engaging a Safety Partner Early in the Drug Life Cycle


    View more
  • January 10, 2021

    Risk minimisation measures: Tracking and effectiveness assessment


    View more
  • January 8, 2021

    Pharmaceutical Product Lifecycle Management: A Regulatory Consideration


    View more
  • January 6, 2021

    RMP Team Collaboration Across Functions


    View more
  • January 6, 2021

    aRMM Implementation Strategy


    View more
  • January 6, 2021

    Regulatory Affairs Services


    View more
  • November 5, 2020

    Human medicinal products containing nitrosamine impurities: Regulatory landscape in the United States and the European Union


    View more
View More

Testimonials

  • Medical Advisor, Medical Affairs
    I must commend the organizational skill, the professionalism, the clarity, the expertise on subject matter, execution excellence that APCER has exhibited in all my projects where I had collaborated…
    Medical Advisor, Medical Affairs
    A leading bio-pharma company
  • Global Clinical Leader
    My experience with APCER has been excellent. The team was very helpful, knowledgeable, responsive and professional with all the work that was needed.
    Global Clinical Leader
    A leading pharmaceutical company
  • Associate Submission Medical Writer
    APCER demonstrated extreme flexibility accommodating changes, and a number of last-minute changes 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 leading bio-pharma 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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    APCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory and technology resources to ensure that patients receive the safest, most effective therapies possible.

    We are an ISO 9001:2015, ISO 27701:2019 and ISO 27001:2022 certified company.

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