About US
A Phase 3 Pharmaceutical company hires Professional SC Resources to provide complete end to end Commercialization Services for a biologics product that was being approved in the U.S. ProSCR provided support with regulatory submission, art work, PV, Packaging and Labeling, Serialization, 3PL set up, and Wholesaler contracts. Note from Customer: "This was so eye opening, our team underestimated what was needed to execute FDA approval and to set up the commercial infrastructure. Glad we hired Robert and his team to execute our activities. Now we are way ahead to launch in the EU and UK."
Our Services
🔹 Regulatory Affairs – Submissions, labeling, health authority engagement (FDA, EMA, MHRA, Health Canada, MOHs)🔹 Quality Management – QMS implementation, GMP compliance, audits🔹 Artwork & Labeling – Mockups, serialization, packaging🔹 Pharmacovigilance – Safety monitoring and reporting🔹 Supply Chain Setup – Network design, logistics, distribution, trade compliance🔹 Market Access – Pricing, reimbursement, HTA strategy🔹 Commercial Readiness – Sales & affiliate setup, marketing, media relations🔹 Lifecycle Management – Product optimization and re-commercialization support
about the Team
the industry need
