At ResolveMass Laboratories Inc., we provide comprehensive Chemistry, Manufacturing, and Controls (CMC) services for INDs and NDAs, supporting pharmaceutical and biotechnology companies through every phase of drug development. Our CMC expertise ensures that regulatory submissions are scientifically robust, compliant with global guidelines, and aligned with FDA expectations—helping sponsors accelerate timelines while reducing regulatory risk.
CMC is the backbone of regulatory success. Inadequate or poorly structured CMC data is one of the most common causes of IND holds and NDA delays. ResolveMass Laboratories bridges scientific excellence with regulatory insight, delivering CMC strategies that withstand agency scrutiny and support confident progression from early development through commercialization.
Advance Your Pipeline with Precision Navigating the complexities of drug development requires a partner who understands the science behind the submission. Explore our full suite of Drug Discovery Services to accelerate your journey from concept to clinic.
Comprehensive CMC Services Designed for Regulatory Success
Our CMC capabilities include:
- Drug substance and drug product characterization
- Analytical method development and validation
- Stability study design and execution
- Manufacturing process development and scale-up
- CMC documentation for IND, NDA, ANDA, and global submissions
- Post-approval CMC change management support
Each service is designed to generate regulator-ready data packages that align with ICH, FDA, EMA, and global regulatory standards. Our scientists understand how reviewers assess CMC sections, ensuring clarity, consistency, and scientific justification throughout the submission.
Secure Your Regulatory Submission with Robust Analytics Reliable data starts with validated methodologies. Discover how our Analytical Method Development and Validation Services ensure your data meets the highest global standards.
IND-Focused CMC Services
For Investigational New Drug (IND) applications, ResolveMass Laboratories Inc. provides phase-appropriate CMC strategies that support first-in-human and early-phase clinical studies. We help sponsors balance speed with compliance by generating fit-for-purpose data that meets FDA expectations without unnecessary delays.
IND CMC support includes:
- Preclinical and Phase I material characterization
- Impurity profiling and risk assessment
- Reference standard qualification
- Clinical supply manufacturing support
- IND Module 3 authoring and review
Mitigate Risk with Comprehensive Nitrosamine Screening Emerging regulatory requirements demand rigorous impurity testing. Contact us today for expert Nitrosamine Analysis to protect your product’s safety and compliance profile.
NDA-Ready CMC Services for Late-Stage and Commercial Programs
For New Drug Applications (NDAs), ResolveMass delivers commercial-grade CMC solutions designed to demonstrate product consistency, quality, and lifecycle control. Our experts support late-phase development and commercialization by generating defensible data packages that withstand in-depth regulatory review.
NDA CMC support includes:
- Process validation and comparability studies
- Long-term and accelerated stability programs
- Analytical lifecycle management
- Manufacturing site readiness and tech transfer
- NDA Module 3 preparation and regulatory responses
Ensure Product Stability Under Every Condition Proactively identify potential degradation pathways before they impact your filing. Learn more about our specialized Forced Degradation Studies for late-stage development.
Our Proven CMC Development Approach
- Strategic Assessment – Evaluate program stage, regulatory pathway, and risk profile
- Customized CMC Roadmap – Develop phase-appropriate, submission-focused plans
- Data Generation & Review – Produce high-quality analytical and manufacturing data
- Regulatory Documentation – Prepare clear, reviewer-friendly CMC sections
- Ongoing Support – Address agency questions, amendments, and lifecycle updates
Validate the Safety of Your Packaging and Delivery Systems Don’t let unforeseen contaminants stall your commercial launch. Partner with us for industry-leading Extractables and Leachables Testing to ensure patient safety.
Why ResolveMass Laboratories Inc. for CMC Services?
Deep Scientific Experience
Our team includes experienced analytical chemists, formulation scientists, and regulatory specialists who have supported multiple IND and NDA submissions across diverse therapeutic areas.
Regulatory-Driven Mindset
We design every experiment, report, and method with regulatory reviewers in mind—minimizing deficiencies and avoiding costly rework.
Quality You Can Defend
Our work is performed under strict quality systems, ensuring data integrity, traceability, and inspection readiness.
Get a Specialized Quote for Your CMC Project Ready to streamline your regulatory path? Contact our expert team today to discuss a customized CMC strategy tailored to your molecule’s unique needs.
Commitment to Quality, Compliance, and Data Integrity
ResolveMass Laboratories Inc. operates under rigorous quality standards aligned with ICH, FDA, and global regulatory expectations. Our documentation, analytical methods, and manufacturing data are built to support audits, inspections, and long-term product success—reinforcing trust with regulators, partners, and stakeholders.
ResolveMass Laboratories Inc. provides end-to-end Chemistry, Manufacturing, and Controls (CMC) services for INDs and NDAs, supporting pharmaceutical and biotech companies with regulatory-ready analytical, manufacturing, and documentation solutions. Our expertise reduces regulatory risk, accelerates approvals, and supports successful drug development from early research through commercialization.
Frequently Asked Questions (FAQs)
CMC services encompass the scientific and technical activities required to define how a pharmaceutical product is developed, manufactured, tested, and controlled for quality. These services generate the data needed to demonstrate that a drug is consistently produced and suitable for its intended use. CMC services are a core requirement for regulatory submissions throughout drug development.
CMC in chemistry, manufacturing, and controls refers to the framework that describes a drug’s composition, manufacturing process, and quality control strategy. It explains how raw materials are transformed into a finished product and how critical quality attributes are monitored. This information allows regulators to assess product safety, quality, and consistency.
Yes, quality control (QC) is a fundamental component of CMC. QC activities include analytical testing, specification setting, and release testing to verify that the drug meets predefined quality standards. These controls ensure batch-to-batch consistency and ongoing compliance throughout the product lifecycle.
The purpose of CMC is to ensure that a pharmaceutical product is manufactured reliably, safely, and with consistent quality. CMC data demonstrates control over materials, processes, and testing methods, reducing risks to patients and regulators. It provides the scientific foundation needed for regulatory approval and long-term product success.
Analytical methods confirm product identity, strength, purity, and quality throughout development and commercialization. Well-validated methods are critical for demonstrating consistency, supporting stability claims, and ensuring regulatory confidence in the product’s control strategy.
Conclusion
ResolveMass Laboratories Inc. delivers trusted, science-driven Chemistry, Manufacturing, and Controls (CMC) services for INDs and NDAs that empower drug developers to move forward with confidence. By combining deep technical expertise, regulatory insight, and uncompromising quality, we help transform promising molecules into approved therapies—efficiently, compliantly, and successfully.
Contact ResolveMass Laboratories
Reference
- U.S. Food and Drug Administration. (2024, November 19). Chemistry manufacturing and controls (CMC) guidances for industry (GFIs) and questions and answers (Q&As). U.S. Department of Health and Human Services. https://www.fda.gov/animal-veterinary/guidance-industry/chemistry-manufacturing-and-controls-cmc-guidances-industry-gfis-and-questions-and-answers-qas
- Popkin, M. E., Goese, M., Wilkinson, D., Finnie, S., Flanagan, T., Campa, C., Clinch, A., Teasdale, A., Lennard, A., Cook, G., & Mohan, G. (2022). Chemistry manufacturing and controls development, industry reflections on manufacture, and supply of pandemic therapies and vaccines. AAPS Journal, 24(6), Article 101. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9514697/
- Patel, D. H., Kumar, B. J., & Patel, A. A. (2017). Preparation and review of chemistry, manufacturing and control (CMC) sections of CTD dossier for marketing authorization. International Journal of Drug Regulatory Affairs, 5(2), 1–12. https://www.ijdra.com/index.php/journal/article/view/196