Unicor Pharma Services

Unicor Pharma Services is a specialized consultancy providing end-to-end Licensing, Regulatory Affairs, Licensing, Quality Compliance, and Market Access solutions to pharmaceutical, biotechnology, and medical device companies globally. We serve clients across: Europe | GCC & MENA | Canada | Australia & NZ | Africa | Emerging markets Our Core Services Include: Regulatory Affairs Our EU focused regulatory expertise covers: • Regulatory strategy development and comprehensive gap analysis • EU Regulatory submission through CP, MRP, DCP or National routes across EU member states/UK. • Dossier authoring (Modules 1–5), eCTD compilation, publishing, and submission • EU DCP slot request and Centralised Procedure (CP) eligibility request coordination • Expert response to health authority queries • Full support for EU GMP inspections and certification • Management of National phase after closure of MRP/DCP and CPs. • PIL readability user testing & bridging report preparation • Translation Services for Product Information (SmPC, PIL, Labelling) compliant with QRD templates • Scientific advice preparation and briefing documentation • Orphan drug and pediatric investigation plan (PIP) applications • Regulatory Medical Writing: Modules 2.4/2.5/2.6/2.7, Module 171, Risk management plans (RMPs), Environmental risk assessment report • Lifecycle Management: Variations, Renewal, MAH transfer, PSUR Other RA services includes • End to End support for Marketing Authorization Applications (MAA) submission (Canada, GCC, AU, NZ and Emerging markets) • Support for Compassionate Use & Early Access Programs • Clinical Trial Submissions & Ethics Approvals Licensing & Strategic Partnerships solutions • Strategic support for In-licensing & Out-licensing deals • Market Intelligence & Partner Identification and CMO sourcing • Product Development & Analytical Services • Contract Manufacturing (CMO) Services • Clinical & BE Study Services • Licensing negotiation and agreement support