IND Modification for Phase I Clinical Trial

IND Clinical Trial Technical Writing in preparation of FDA submission
  • Area: Greater Seattle Area
  • Project Type: Regulatory Affairs, Technical Writing

About this Project

OBJECTIVE

Client received FDA responses to initial Phase I Clinical Trial submission. Client required support in ensuring documents were modified and complete for FDA submission.

SERVICES

PSC® supported a small, start-up biopharmaceutical company with their Investigational New Drug (IND) application. With commentary from the FDA and a short time-line, PSC provided updates and modifications to the IND Phase I Clinical Trial Submission to ensure FDA approval. PSC® also provided Strategies for Optimization of Design of Forms to set the client up for success for future submissions.

PROJECT SUCCESS

PSC® has successfully completed the IND Modification for Phase I Clinical Trial within scope, schedule, and budget, and received outstanding feedback from the client’s Executive Team.

Related Projects

Greater Los Angeles Facility Expansion

Commissioning, Qualification, Validation and Engineering services for the clients manufacturing facility since its inception.

Greater Los Angeles Varied Services

Commissioning, Qualification, and Validation (CQV) services for one of the clients plants since the mid 1990’s to the present.

Greater Los Angeles Cleaning Validation

PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.

How Can We Help You?

[ninja_form id=6]