For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
With escalating development costs and increasing challenges in the biopharma industry, it is critical to effectively optimize the lifecycle of your product.
With proven solutions to efficiently manage every aspect of the product’s lifecycle in approved markets, our services include:
Regulatory maintenance submission: Submission planning, coordination, and management of post-approval submissions, allowing you to focus resources on higher value-add regulatory tasks, efficiently managing workload.
Annual Product Reviews (APRs): Creation and compilation of APRs across a wide range of therapeutic areas, crafting concise but highly compelling storylines to maximize the likelihood of appropriate product positioning with regulatory agencies.
Drug Master File (DMF) submission and maintenance: DMF preparation and maintenance and submitting supplemental applications.
Development Safety Update Report (DSUR): DSURs preparation, in compliance with ICH E2F using data checklists, templates, and quality control procedures specifically tailored to DSUR production.
Product Safety Update Report (PSUR): PSUP writing, compilation, publishing and submission, providing process efficiency with quality standards.
Regulatory data maintenance: Regulatory information management (RIM) and XEVMPD and IDMP data entry, allowing you to focus resources on higher-level tasks while managing peaks and values in workload efficiency.
Regulatory intelligence: Tracking, analysis, and reporting regulatory guidance information, keeping internal teams current on changing trends and requirements.
Technical writing: Authoring for CTD/eCTD Module 1 and Module 3 documents along with CMC authoring and interpretation.
Original and roll-out application: Submission planning, coordination, and management of original and rollout applications. We compile, publish, and dispatch submissions in CTD, eCTD, NeES, hybrid, and paper formats.