PharmaLex offers full lifecycle management for the submission process with flexible options for report-level publishing, compilation of major applications (IND, NDA, BLA) and lifecycle maintenance. Our regulatory affairs professionals are experienced in an array of electronic formats, including electronic Common Technical Documents (eCTD), and Structured Product Labeling (SPL).
Radiopharmaceuticals in diagnostics and therapy form a special product group with specific regulatory requirements in terms of production, distribution, and radiation protection. Necessary safety precautions and often very short half-lives pose special challenges for the business and require a different conceptual approach compared to „conventional“ medicinal products.
PharmaLex offers full support along the Validation Lifecycle (VLC) for your New Product Introductions and Technology Transfer projects. Our Validation Professionals are not only validation experts, but process experts. And by this we mean experts in all types of manufacturing processes for all types of dosage forms.
Meetings with the leadership and review staff of the US Food and
Drug Administration (FDA) are one of the most important resources
available to sponsors seeking agency approval in the US. PharmaLex
recommends holding face-to-face and teleconference meetings with
FDA throughout the product development timeline.
The Medical Device Regulation (MDR – (EU) 2017/745) and In-Vitro Diagnostic Regulation (IVDR – (EU) 2017/746) present a significant challenge for medical device manufacturers. Our highly professional and experienced medical device team are available to provide support as required.
PharmaLex’s dedicated Medical Device team offers the breadth and depth of expertise to provide comprehensive support throughout the product lifecycle. We employ proven methodologies and hands-on support to optimize
and customize quality and regulatory solutions which are delivered on time, in budget and with the highest quality.
Limited internal resources and minimal experience with RIM implementation projects
- US-headquartered biopharmaceutical company with European affiliate
- First NDA approved; further, NDAs planned
- Fast-growing company with increasing Regulatory needs
- Limited resources for project management and operational work during configuration and implement phase
- Minimal experience with RIM implementation projects and no experience with Veeva Vault
PharmaLex offers regulatory compliance services that address the new FDA requirements that have been implemented to govern the tobacco and vape industry.