Integrated CMC Support from Development to Commercialization
ChemPartner delivers integrated small molecule CMC services that support drug candidates from early development through IND, NDA, and commercialization. Our coordinated platform combines API development and manufacturing, formulation development, analytical characterization, solid-state R&D, process optimization, pilot-scale production, large-scale manufacturing, and quality management within a unified development strategy.
Whether you are advancing a preclinical asset or preparing for late-stage manufacturing, our teams help streamline development, reduce scale-up risk, and generate regulatory-ready supporting data.
Why Partner with ChemPartner for Small Molecule CMC
ChemPartner combines scientific expertise, integrated development capabilities, and scalable manufacturing support within a single coordinated platform.
More than 50% of the scientific team consists of Ph.D. and M.S.-level scientists supporting complex development programs across drug substance and drug product activities.
Why Small Molecule CMC Matters
A robust CMC strategy helps establish scalable manufacturing processes, define product quality, and support regulatory submissions with reliable development data.
Our integrated approach aligns technical development, manufacturing execution, and quality oversight to help accelerate program progression.
Core service areas
Looking for End-to-End Small Molecule CMC Support?
From API development to pilot manufacturing and formulation optimization, ChemPartner provides integrated support across the full development lifecycle.
Infrastructure & Platform Capabilities
API Pilot Platform
The Shanghai LinGang pilot platform includes GMP and non-GMP infrastructure supporting reaction, filtration, drying, and scale-up operations.
Large-Scale Manufacturing
ChemPartner supports Phase II, Phase III, and NDA-related manufacturing programs with scalable production infrastructure.
Quality Management System
Development and manufacturing activities are supported by a structured quality management system covering:
Scale Your Program with Confidence
Discuss pilot-scale manufacturing, process transfer, or late-stage production support with our CMC and manufacturing teams.
Case Studies & Development Timelines
The deck highlights multiple examples demonstrating coordinated execution across API, formulation, and solid-state development programs.
These case studies reinforce ChemPartner’s ability to coordinate technical development, manufacturing readiness, and regulatory support within defined timelines.
Frequently asked questions
What is CMC in drug development?
CMC refers to Chemistry, Manufacturing, and Controls activities that support the development, production, quality, and regulatory readiness of drug substances and drug products.
Do you support small molecule API development?
Yes. ChemPartner supports new drug API development, process optimization, IND support, advanced intermediates, and CDMO manufacturing across preclinical through Phase III stages.
Do you provide formulation development support?
Yes. Services include preformulation research, formulation and process development, pilot-scale amplification, stability studies, and dossier preparation across multiple dosage forms.
What analytical services are included?
Capabilities include analytical method development and validation, impurity characterization, structure elucidation, stability studies, microbial testing, and formulation evaluation support.
What pilot manufacturing capabilities are available?
The Shanghai LinGang pilot platform includes GMP and non-GMP infrastructure, Class D cleaning room support, reaction vessels, cold storage, warehousing, and waste treatment systems.
Do you support IND and NDA-related programs?
Yes. The platform supports IND, NDA, and commercialization goals through integrated development, manufacturing, analytical, and quality capabilities.
Ready to Advance Your Small Molecule CMC Strategy?
Whether you need API development, formulation support, analytical characterization, solid-state studies, or pilot-scale manufacturing, ChemPartner can help build an integrated CMC path aligned with your development goals.
- Connect
Speak With a CMC Scientist
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- REQUEST
Request a CMC Consultation
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