REGULATORY SERVICES
Our regulatory team is experienced in drug, biologic, vaccine, gene therapy and medical device regulatory requirements. Strategic advice on all stages of development is provided to assist companies navigating the FDA requirements. Each regulatory expert has more than 25+ years in the pharmaceutical industry and brings a wide range of experiences from drug discovery to market approvals.
We work with the project team to develop strategies to ensure a successful path throughout the development phases. A dedicated regulatory expert is assigned for the duration of the project to provide regulatory advice for each stage of development and participates in team meetings. We offer advice that is what you need to know, not always what you want to hear. This approach leads to a better success rate with regulatory authorities and the overall project direction.
Our regulatory expert also provides writing, preparation and compilation of regulatory submission documents and annual reports so you have the same individual providing you all the services. Additional assistance is provided by other LBR regulatory experts when the assigned regulatory expert requests help.
REGULATORY STRATEGIC CONSULTING
We want you to be successful, so our regulatory experts work with your team to build the most efficient and effective regulatory strategy. We do not have a set way that a program has to progress but customize each program to produce an outcome of market approvals. We continue to review the program to re-define milestones, streamline development timelines, and assess risks throughout the development program to manage timelines and costs.
Our Regulatory Affairs experts offer guidance and support with FDA meetings. We will help you prepare documents that meet FDA expectations while building a relationship with the Agency.
Gap Analysis of R&D Consulting
FDA Authorized Representative for foreign entities
Representation with federal / state agencies
Regulatory Project Management
REGULATORY SUBMISSIONS
If you need assistance with the finalization of a regulatory document, our regulatory experts review the document and ensure it is accurate, consistent, and complies with submission requirements. Once the document is final, we do a 100% quality control review of the submission to confirm no further issues are identified. We also will do a quality assurance audit of the submission prior to electronically submitting to the FDA.
Review of clients’ regulatory submission documents
eCTD submission preparation
QC regulatory submissions
eCTD submission to regulatory authority