About Us
ABOUT US
ABOUT US
Company Overview
Company Overview
Peak Pharma Consulting assists both multi-national pharmaceutical clients and virtual pharma/biotech companies from early stage development through commercial manufacturing. We provide an end to end CMC service that encompasses regulatory and technical hands on leadership. Our objective is to fully integrate with the client and roll up our sleeves to accomplish success for the client and program.
Every customer is unique. That’s why we customize every one of our plans to fit your needs. Whether it’s a small strategy or a comprehensive effort, we’ll sit down with you, listen to your needs, and prepare a customized plan. We are committed to providing personalized and affordable regulatory and technical services for all stages of development.
Our Team
Our Team
Sam Salamone, MS, MBA, RAC
Sam is the owner and principal consultant of Peak Pharma Consulting. He has over 15 years of experience in regulatory CMC, technical API and drug product development, and end to end project management for small to multi-national corporations. He has extensive broad knowledge on pharmaceutical and combination product CMC regulations with expertise in devising overall CMC program and regulatory strategies. His area of expertise include: end to end project management, IND/IMPD/DMF/NDA/MAA regulatory preparations, post-approval compliance and reporting, development and technical transfer leadership, and manufacturing strategy for commercialization. Sam began his career as a process chemist and technical operations leader for Vertex Pharmaceuticals and then moved to Johnson and Johnson holding several regulatory and scientific positions over 10 years in pharmaceutical and combination products development.
Experienced Leadership
Your project will be handled by experts every time. We make sure you have the most experienced professionals working for you.
Quality Guaranteed
You’ll find the support you need to ensure that things runs smoothly. We’re here to help you with any questions.