Ready to explore a partnership?
Flexible partnerships. Proven delivery. Global regulatory reach.
Landmark Medicines is a specialty generics development and licensing. With over two decades of experience in complex formulation and drug delivery, we work with pharmaceutical and biotech companies to expand portfolios through high-barrier, differentiated generics.
Whether supporting early-stage development, licensing opportunities, or full technology transfer, our collaboration models are designed to align with your strategic, financial, and regulatory objectives.
Our Partnership Model
We structure partnerships to match each partner’s goals, risk profile, and timeline:
Co-Development
Joint development from feasibility through clinical proof-of-concept, with shared investment and aligned value creation.Out-Licensing
Access to fully developed or near-registration generic candidates for commercialisation across defined territories.In-Licensing
Integration of your molecule or technology into our platforms, with full development through to regulatory submission.Technology Transfer & Manufacturing
Transfer of existing formulations into our cGMP-aligned environment for scalable, cost-efficient production.Targeted Development Services
Focused, fee-for-service engagements (e.g., bioavailability enhancement, stability programmes, CMC dossier development) with partner-retained IP.
We adapt to your business model — from discrete projects to fully integrated, risk-sharing partnerships.
Partner Value
Partnering with Landmark Medicines provides a structured path to accelerate and de-risk complex generic programmes:
De-risked Development
Established platforms across soft gels, nasal delivery, depot injections, and microneedles
Integrated analytical and stability capabilities to streamline development
Access to pre-validated formulation strategies for select APIs
Regulatory Execution
Experience across US FDA, UK MHRA, and EU regulatory frameworks
End-to-end dossier development
Proven capability in navigating regulatory pathways and information requests
Deep experience. Disciplined execution. Measurable outcomes.
Our team has been active in complex drug delivery and specialty generics for over 20 years, with a strong track record across formulation, clinical development, and regulatory delivery:
12+ complex injectable programmes advanced from feasibility to clinical or regulatory stages
Multiple transdermal and advanced delivery systems with validated pharmacokinetic performance
Differentiated oral and topical formulations, including modified and targeted release technologies
Clinical programme experience from early phase through pivotal studies with multinational partners
Regulatory submissions across:
US FDA
UK MHRA
EU pathways including BfArM
We bring practical, execution-focused experience across three of the world’s most demanding regulatory environments — applied directly to your programme.
Business Development
Ready to explore a partnership?
Whether you have a defined asset, a technical challenge, or an interest in licensing opportunities, our team engages with discretion and speed.
Use the enquiry form below, and we will respond within two business days.