REGULATORY SERVICES
LBRIA provides strategic regulatory services to support the development and approval of drugs, biologics, vaccines, gene therapies, and medical devices. Our regulatory team offers expert guidance across all stages of development, helping sponsors navigate FDA and global regulatory requirements with clarity and confidence.
Each LBRIA regulatory expert brings a breadth of experience spanning early discovery through market approval. This depth of knowledge enables practical, strategic advice that supports efficient development and successful regulatory outcomes.
LBRIA partners closely with project teams to develop and execute regulatory strategies tailored to each program. A dedicated regulatory expert is assigned for the duration of the project, providing continuity and participating directly in team meetings to guide decision-making at every stage.
In addition to strategic consulting, LBRIA regulatory experts provide hands-on support for the preparation, compilation, and submission of regulatory documents and annual reports. This integrated model ensures consistency and accountability, with additional subject matter expertise available as needed to support complex programs.
REGULATORY STRATEGIC CONSULTING
LBRIA regulatory experts work collaboratively with sponsors to develop efficient, risk-aware regulatory strategies designed to achieve timely market approval. We customize each program based on its unique characteristics and continuously reassess milestones, timelines, and risk to optimize development efficiency and control costs.
Our services include:
Regulatory strategy development and lifecycle planning,
FDA meeting preparation and agency interaction support,
Gap analysis and R&D regulatory consulting,
Regulatory project management,
FDA Authorized Representative services for foreign entities,
Representation with federal and state regulatory agencies.
REGULATORY SUBMISSIONS
LBRIA provides comprehensive support for the review, preparation, publishing and submission of regulatory documents. Our regulatory experts ensure that all submissions are accurate, consistent, and fully compliant with applicable requirements. Each submission undergoes a rigorous quality control review and quality assurance audit prior to electronic submission to the regulatory authority.
Our submission services include:
Review and refinement of regulatory submission documents,
Integrated summary of safety and efficacy (ISS/ISE)
eCTD submission preparation and publishing,
Quality control and quality assurance of regulatory submissions,
Electronic submission to regulatory authorities.
