Together for
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.
