Radiopharmaceutical lifecycle solutions
Early-stage research delivered by HUAHE, connected with integrated process and analytical development, technology transfer, and manufacturing for clinical and commercial supply.
At each stage, the work addresses three questions: Is the technical approach feasible? Is the evidence sufficient? Are the conditions for the next step in place? Each service can stand alone or connect under an agreed Project Master Plan.
Connected expertise
Whether you need a single research study, a focused development package, or integrated delivery across several stages, the scope begins with your program objective.
HUAHE undertakes early-stage radiopharmaceutical research to help you decide which candidates merit further development.
Explore service CDMO · Process & Analytical DevelopmentHUAHE integrates process and analytical development to build the process understanding needed for scale-up, process control and technology transfer.
Explore service CDMO · Technology TransferHUAHE supports the transfer of radiopharmaceutical processes and analytical methods to receiving sites.
Explore service CMO · Manufacturing & Supply IntegrationHUAHE integrates manufacturing and supply activities to support your clinical and commercial milestones.
Explore serviceEach stage gate confirms inputs, outputs, responsibilities and conditions for continuation. The evidence progresses from consistent radiolabeling and purification, through analytical and in vivo findings, to process control, transferability, and complete manufacturing and supply records.
CRO · Early-Stage Research
HUAHE undertakes early-stage radiopharmaceutical research to help you decide which candidates merit further development. Research brings together target biology, molecular properties, radiolabeling feasibility and in vivo behavior to compare candidates, identify risks and define the evidence needed for the next decision.
CDMO · Process & Analytical Development
HUAHE integrates process and analytical development to build the process understanding needed for scale-up, process control and technology transfer. Under the Project Master Plan, product quality objectives guide studies of starting materials, radiolabeling, purification, formulation, analytical methods and stability, accounting for radioactive decay, radiolysis and narrow operating windows.
CDMO · Technology Transfer
HUAHE supports the transfer of radiopharmaceutical processes and analytical methods to receiving sites. Within the authority granted by the client or technology owner, we assess gaps between development knowledge and receiving-site capabilities, develop the transfer plan and coordinate training, on-site implementation, engineering or trial runs and analytical method transfer, with documentation supporting acceptance by the receiving site.
CMO · Manufacturing & Supply Integration
HUAHE integrates manufacturing and supply activities to support your clinical and commercial milestones. Within the agreed scope, we match qualified manufacturing sites to project requirements, coordinate manufacturing, review delivery documentation and manage client communication. Licensed manufacturers operate under their own quality systems and retain responsibility for manufacturing, testing and batch release.
HUAHE integrates clinical and commercial supply within the agreed project scope. Qualified, licensed manufacturers operate under their own quality systems and retain responsibility for manufacturing, testing and batch release. Manufacturers, marketing authorization holders and sponsors retain their respective statutory responsibilities.
Connect with HUAHE
Tell us your current stage, the question you need to address, and the outcome you have in mind.
