Sam Salamone
Owner / Principal Consultant at Peak Pharma Consulting
- Role
- Owner Principal Consultant at Peak Pharma Consulting
- Location
- Flagstaff, AZ, US
- LinkedIn followers
- 500 followers
About Sam Salamone
A leader and hands-on consultant with over 15 years of Regulatory CMC, Project Management, and Technical Operations for Pharmaceutical companies. Extensive broad expertise on pharmaceutical and combination products CMC regulations and guidance documents with leadership in devising overall CMC program and regulatory strategies. CMC program management to design and implement strategic road maps for complex programs with oversight and ownership of technical transfers for drug substance and drug product manufacturing. Champion of phase-appropriate and risk-based approaches for each phase of pharmaceutical development.
Experience
Owner Principal Consultant
Mar 2019 — Present · Flagstaff, AZ, US
Regulatory and Technical CMC principal consultant providing expertise to pharmaceutical companies ranging from multi-national corporations to virtual based organizations for early stage through life-cycle management. Services include: Regulatory Affairs CMC • IND/IMPD/DMF/NDA/MAA expertise for drug substance and drug product eCTD authoring • Design and implement regulatory strategies for pharma and combo products for early stage through post-approval • Regulatory agency meeting CMC oversight (Pre-IND, EOP2, Pre-NDA, Type C) • Change control management for all stages • Technical CMC report authoring Project Management • CMC team management and oversight to drive cross-functional team members to overall program success • Microsoft project and other dedicated software expertise in end to end program CMC management • Develop and implement strategic road maps for complex products and supply chains Technical Transfer and Validation • Full oversight and ownership of process and analytical transfer to contract manufacturing sites • Due diligence and guidance on CMO selection for DS and DP • Technical review of GMP documentation for manufacturing • Project timeline oversight and defining key milestones with potential road blocks for technical site transfers • Specializations in API manufacturing, tablet formulations, and various aseptic manufactured drug products • Couple technical transfer activities with regulatory requirements
Education
Florida State University
M.S., Organic Chemistry
University of Florida - Warrington College Of Business
MBA
Merrimack College
B.S., Chemistry
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.