How we can help
High-quality regulatory submissions
A high-quality submission is one that presents data in a clear and concise manner so it can be appropriately assessed by regulators.
A well-connected storyline lessens the number of inquiries and smoothens the path to approval of regulatory submissions.
Regulatory strategy
Successful regulatory meetings require good planning and strategic positioning of the topics for which the sponsor is seeking advice.
We help you define clear objectives, prepare the pertinent questions, and define the company position(s) supported by the relevant data.
Formal meetings
LAIZ works with your during the meeting preparation and advocates for you at formal meetings (i.e., Advisory Committee meetings).
Module 2&5 - Immunogenicity
LAIZ can prepare your Integrated Summary of Immunogenicity (ISI) for MAA / BLA (novel biotherapeutics & biosimilars) and support responding to questions arising during regulatory review.
Module 3
LAIZ can conduct the review and gap analysis of Module 3 sections of your biotherapeutics applications and support responding to questions arising during regulatory review of IND, BLA, and prior approval supplements (PAS).
Get in Touch!
Contact us to schedule a consultation and enhance your product success.