Start with technical fit
Discuss product type, stage, services and target markets to establish scientific fit.
INTERNATIONAL PARTNERSHIPS
Your U.S. scientific partner.
Explore U.S.-based formulation development, analytical services, stability programs and clinical trial material manufacturing with SmaBio Labs in Research Triangle Park, North Carolina.
Discuss your U.S. program
DEFINE YOUR U.S. REQUIREMENTS
Start with the science. Align the practicalities.
Confidentiality and technical review
Request an NDA before sharing proprietary information. Agree which records, methods and material information are needed.
Material transfer and coordination
Discuss classification, handling and storage, shipping responsibilities and applicable import documentation before sending samples.
Communication across time zones
Share location, preferred meeting times and time zone. Agree contacts, reporting and escalation arrangements.
Quality and sponsor responsibilities
Discuss documentation and audit needs. Define each party’s responsibilities and the regulatory-support activities within scope.
Scope, proposal and onboarding
Align deliverables, dependencies and timing. Confirm material-transfer and project-initiation arrangements.
A SHARED ENGAGEMENT PROCESS
From first inquiry to agreed work.
Scope and timing are discussed for your specific program. Agree material-transfer arrangements and responsibilities before sending samples.
INTERNATIONAL PROGRAM COORDINATION
Practical alignment for a U.S.-based program.
Define the scientific scope first, then agree how teams, information and materials will be coordinated.
Communication & review
Discuss time zones, project contacts, meeting cadence and how technical questions will be resolved.
- Identify scientific and operational contacts
- Agree review points and reporting expectations
Documentation & responsibilities
Align required documents, confidentiality arrangements and the intended use of study outputs.
- Confirm language and format expectations
- Define sponsor and service-provider responsibilities
Material-transfer planning
Agree material suitability, receiving arrangements, handling and shipment before dispatch.
- Discuss shipment and import responsibilities
- Confirm required material and shipping documentation
THE SCIENCE BEHIND THE SERVICE
Capabilities you can examine.
Explore the methods, dosage forms and scientific disciplines relevant to your product.
01
FORMULATE
Product Development
Pre-formulation, formulation and process development for complex drug products and combination systems.
02
CHARACTERIZE
Small-Molecule Analytical Services
Analytical development, characterization and testing for drug substance, drug product and related materials.
03
CHARACTERIZE
Biologics Analytical Services
Structural, purity and heterogeneity analysis for ADCs, proteins and polypeptides.
04
EVALUATE
Stability Storage & Testing
Study design, storage and analytical testing to understand product change over time.
05
CLINICAL SUPPLY
Clinical Trial Material Manufacturing
Sterile and non-sterile clinical trial material support from preclinical development through Phase I and Phase II.
06
CHEMISTRY
Drug Discovery & Process Development
Discovery and process chemistry connecting early research with API and intermediate development.
07
CHEMISTRY
Custom Synthesis
Synthesis support for API intermediates, reference standards and impurities.
A TECHNICAL CONVERSATION STARTS HERETell us what your
Tell us what your
product needs to do.
Share your product, scientific challenge and next milestone. Request an NDA before providing proprietary details.