Licensing
We provide comprehensive support and coordination for in-licensing and out-licensing activities across pharmaceutical, biotech, and medical device products—empowering your organization to expand portfolios, access new markets, and forge successful partnerships.
Our Services Include:
- Strategic business development support for licensing and partnership opportunities.
- End-to-end business development supports to identify, evaluates, and execute in-licensing and out-licensing deals.
- Expert business development services to expand product portfolios and market presence through licensing strategies.
- Business development support tailored to drive strategic collaborations, licensing deals, and market expansion.
- Licensing Negotiation & Agreement Support
- Market Intelligence
- Identification of Contract Manufacturing Organization
Strategic Partnerships
Our network delivers flexible, end-to-end services for Product development, Analytical, Contract Manufacturing & Clinical & Bioequivalence studies.
A. Product Development and Analytical Services
Our network delivers flexible, end-to-end R&D solutions:
- Product Development Services
- Analytical Method Development, Method Validations, Method Transfer Services
- Elemental impurities risk assessment report preparation & analytical testing services
- Nitrosamine impurities risk assessment report preparation & analytical testing services
- Stability study services
B. Contract Manufacturing Services
Our CMO network delivers flexible, end-to-end manufacturing solutions for various dosage form products:
- Oral solid dosage (tablets, capsules)
- Liquids, suspensions, syrups
- Topical formulations (creams, ointments, gels)
- Sterile injectables and ophthalmics
- Biologics and biosimilars
GMP-Compliant Manufacturing Facilities
- EU-GMP
- US-FDA
- WHO-GMP
- PIC/S certified plants
Packaging & Labelling
- Primary and secondary packaging
- Multi-lingual labelling per export market
Tech Transfer and Scale-up
- Seamless technology transfer from R&D to production
C. Clinical and Bioequivalence (BE) Studies Services
We provide comprehensive support for designing, planning, and managing clinical and bioequivalence studies to ensure regulatory compliance and successful product registration.
- Biostudy Monitoring
- Design and protocol development for Phase I–III clinical and BE studies
- Support for study feasibility, site selection, and CRO coordination
- Reference product or Comparator product selection and procurement of RLDs
- Preparation of study documents [Investigator’s Brochure (IB), Informed Consent Form (ICF), Case Report Form (CRF), and Clinical Study Report (CSR)]
- Regulatory submissions for clinical trial approvals (CTA/IND/IMP)
- Oversight of data integrity, GCP compliance, and bioanalytical validation
- Strategic advice for global study alignment (EU, GCC, MENA, CIS, Canada)
- Advise on biowaiver strategy
Get In Touch
+91 9099123156bd@unicorpharma.com