Pharmaceutical manufacturing consultancy
Small molecule contract manufacture and product development consultancy for the biotech and pharmaceutical industry from candidate stage to clinical development
How we can help
Supplier selection
Aligned with your business objectives and the technical requirements of the project, we can identify and recommend the most suitable CDMOs to manage the development and delivery of both Drug Substances and Drug Products. Leveraging our extensive experience in contract manufacturing across the US, Europe, and Asia, we will help you find the optimal partner to meet your needs.
RFP & contract negotiation
We will develop a comprehensive Request for Proposal (RFP) tailored to your specific project requirements, ensuring that all technical and commercial aspects are clearly defined. Acting as your representative, we will lead negotiations with the selected suppliers to ensure the proposals align with both the project scope and your budget.
Project management
We will manage the supplier relationship on your behalf, overseeing the entire project lifecycle to ensure seamless execution. This includes proactive problem-solving, issue resolution, and managing any scope changes that may arise. By acting as your single point of contact, we streamline communication and coordination with the CDMO, simplifying project management and reducing the administrative burden on your team.
Regulatory support
We offer expert guidance on regulatory CMC (Chemistry, Manufacturing, and Controls) strategy, ensuring alignment with global regulatory requirements throughout your product's development lifecycle. We can support the preparation of critical regulatory submissions, including the Common Technical Document (CTD) Module 3, which covers the quality aspects of Drug Substances and Drug Products, as well as the Investigator's Brochure (IB) for clinical trials.
Development strategy
We offer strategic guidance to help integrate CMC across all aspects of your development program, drawing on our expertise in:
CMC / manufacture Clinical supply
Regulatory INN nomenclature
IND enabling Business development
Non-clinical studies Competitive landscape
Intellectual Property Disease selection
Due diligence
We can help to conduct due diligence on pre-clinical and clinical stage assets for companies interested in acquiring new assets, or as part of a portfolio review or GAP analysis.
Rob Moore
Rob Moore (MChem) is the founder of RESOLVE Pharma, with nearly two decades of experience in the pharmaceutical and biotechnology industries. His expertise spans the entire drug development lifecycle, from discovery to commercial manufacturing, across the US, Europe, and Asia.
Rob began his career in Drug Discovery at GSK in the UK, followed by a role in Process Development at Pfizer. In 2011, he relocated to Singapore to join GSK’s commercial manufacturing site as a Product Technical Specialist. He later transitioned to manage contract manufacturing and outsourcing for a diverse portfolio of products in India and China.
In 2015, Rob joined ASLAN Pharmaceuticals, a biotech start-up in Singapore, where he oversaw the development, manufacture, and supply of four clinical-stage assets. His role eventually took him to Shanghai, where he lived for three years, collaborating closely with Chinese CDMOs.
In 2019, Rob became the program lead for farudodstat, a small molecule asset, and successfully advanced the program into a new therapeutic area, conducting a Phase 2 clinical trial in the US.
Rob has also served as a Director and Board Member of JAGUAHR Therapeutics, a discovery-stage oncology venture, where he was responsible for overseeing all business operations and administrative activities.
Currently, Rob works with biotechnology and pharmaceutical companies, providing strategic support and expertise to guide their product development efforts.
Let's talk
Need support on your product development project?
Let's have a conversation to see how I can help...
