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
Company Details
- Founded
- -
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- http://www.unicorpharma.com
- Keywords
- Global Regulatory Submissions (CTD/eCTD, MAA, Variations, Renewals)Global Regulatory Submissions (CTD/eCTD, MAA, Variations, Renewals), EU, GCC, and MENA Regulatory Strategy & Intelligence, Regulatory Due Diligence for Licensing & Strategic Partnering, In-Licensing / Out-Licensing & Market Access solutions, EU GMP Audit Support Services, Clinical Trial Applications, GCP Documentation & Ethics Approvals, GMP/GDP Audit Readiness & Quality System Support.
Unicor Pharma Services Questions
Unicor Pharma Services's website is http://www.unicorpharma.com
Unicor Pharma Services's LinkedIn profile is https://www.linkedin.com/company/unicor-pharma-services
Unicor Pharma Services's industry is
Pharmaceutical Manufacturing
Unicor Pharma Services's top competitors are
Adept Pharma And Bioscience Excellence Private Limited,
Unicor Pharmatech Llp,
Plastic Is Fantastic,
Ftf Pharma Pvt. Ltd.,
Pharmalite,
Color Theory Private Ltd.,
Tedis Pharma Mali,
Medsurge Healthcare,
Bkm Health Pvt Ltd,
Cmpl World.
Unicor Pharma Services's categories are Pharmaceutical Manufacturing
Unicor Pharma Services's founding year is 2025
