Mr. Monsour – Regulatory Writer with CSR, IND and NDA Writing Experience
Mr. Monsour holds an MSc in Human Physiology and Kinesiology. He is a career Scientist and Regulatory Writer, studying stress physiology, medical science, biopharmaceutical development, and manufacturing. Focusing on generating essential regulatory documents compliant with FDA and EMA standards, Mr. Monsour keeps the target audience of Regulatory Authorities in mind when working with clients. It is essential that the story emerging from the data is ironclad, and guides the reviewers through the process, leading to reduced regulatory requests and turnaround time.
Mr. Monsour’s ability to pull key stakeholders from various departments within an organization, and to create a shared language between them, is his key to streamlining Regulatory deliverables that capture the story of drug development and testing. His vast experience with medical physiology research, and fluency with HPLC, ELISA, qPCR, Sterility Testing, and Animal Studies, among other key analytical and biocompatibility studies, is key to tying together a robust IND submission to pivot the client into approval for Phase I and Phase II clinical trials.
As a previous Regulatory Writer for a contract development and manufacturing facility under the direction of the US Department of Defense, Mr. Monsour served as the bridge between various departments, helping to generate key documents for IND and BLA filings.
Regulatory Writer Areas of Expertise:
- Biocompatibility and Cytotoxicity Studies: Proper Pre-Clinical testing is essential to demonstrate drug/therapy safety. This starts with developing a protocol that will address all regulatory needs. Finally, summaries of all study reports need to tell the story of a product’s safety.
- Analytical Development and Technology Transfer: Safe and effective drug development begins in the laboratory, including validated analytical testing methods. This is essential to proper stability studies, raw materials testing, and possible sterility issues, all needing to be addressed in any IND or BLA filing.
- Assessing Quality Management Systems: A QMS system is dynamic and evolving as the client’s manufacturing capabilities grow. The QMS and appropriate risk assessments/mitigations are vital in any Regulatory filing.
- Regulatory Compliance and Vigilance: As a Regulatory Writer, Mr. Monsour remains updated with the ever-changing regulatory landscape in the US and EU.
Expert Support for many Regulatory Writing needs, including, but not limited to:
- Clinical Study Reports (CSRs)
- Protocols: Drug Product/Substance Stability, Analytical Methods, Preclinical Testing, etc.
- IND and NDA submissions
- Common Technical Document (CTD) preparation
- Module 2 and Module 3
- Items 2.1.S and 2.1.P of Investigational Medicinal Product Dossier
- Risk Management Plans (RMPs)
- Briefing Documents for FDA/EMA meetings
- Support for Pre-License Inspection (PLI)
As a passionate versatile Regulatory Writer, Mr. Monsour is skilled in taking complex information and making it clear and concise for the target audience. Mr. Monsour brings his diverse background, adaptability, team management skills, and regulatory insight to your talented team, supporting you through every phase of the regulatory lifecycle while keeping projects on track.
To work with Regulatory Writer Mr. Monsour, please visit our quote page and request him in the description area.