Services

Regulatory Submissions and Scientific Writing

Simulations Plus can prepare the pharmacology sections of documents — including IND, CSR, EOP2a briefing book, SAP, FTR, CTD, and NDA — to support your important regulatory milestones. We’ve developed taxonomies that not only guide the writing of these documents, but make sure you’re addressing all the critical components that will be used throughout the lifecycle of drug development.

Our goal is to minimize or eliminate the questions posed by regulatory reviews, while balancing the cost and time it takes to develop any of these documents. Our analysis plans and reports also help anyone — from a new team or employee to a licensing company to a regulator agency — understand what was done and why, which reduces the need for rework.

Technical Report Writing

At Simulations Plus, we pride ourselves on the completeness of the technical reports we submit to regulatory authorities. Our goal is to minimize or eliminate the questions posed by regulatory reviews, while balancing the cost and time it takes to develop a report. Our reports also allow a new team or employee (or a company you license your drug to) to be able to know what was done and why — giving you confidence and reducing the need for rework.