Drug Development Lab Services for INDs, NDAs, and FDA Information Requests
The drug development process is complex, but regulatory success shouldn't be uncertain. Our expert team navigates the complex path from discovery through development and approval of a marketable drug product, leveraging robust formulation development expertise, a team of experienced analytical chemists, and strategic CMC expertise to accelerate your success.
From early-phase development to responding to regulatory agencies, CMC Pharma specializes in drug formulation and other comprehensive services to help you move forward with confidence.
We Offer Expert Solutions:
Formulation Development Expertise:
From traditional dosage forms to complex drug delivery systems, we have decades of proven experience.
Proven Solubility and Stability Solutions:
Overcoming solubility and stability challenges for hard-to-formulate compounds is our specialty.
Regulatory Compliance:
Our cGMP labs are FDA inspected and our scientific staff ensures FDA, ICH, and global regulatory standards are met.
Manufacturing Enablement:
From pre-formulation to manufacturing oversight, we are your partner in your drug development journey.
End-to-End CMC Solutions for Successful Regulatory Submissions
IND & NDA Submission Support
Drug substance and drug product development strategy & study execution
QbD including specification setting, process control guidance, CPPs, and CQAs
Analytical method development and validation
ICH Stability study design and execution
Process development, scale-up, and validation
Authoring of CMC sections (Module 3) for eCTD including FDA-ready documentation
Responding to an FDA Request
Comprehensive gap analysis and root cause assessment
Design and execution of required studies (stability, validation, specs)
Drafting strategic regulatory response
Support for Complete Response Letters (CRL), Information Requests (IR), and Discipline Review Letters (DRL)
Preparing briefing packages for FDA meetings
Lifecycle and Post-Approval CMC Support
Technical support for SUPAC submissions
Support for line extensions, including new formulations and packaging
Amendments, supplements, and annual updates
Post-approval changes and comparability protocols
Tech transfer and manufacturing scale-up strategy
Ongoing regulatory compliance consulting
CMC Pharmaceuticals Provides Comprehensive Services, Including:
Pre-formulation Studies
Compound characterization
Physicochemical property determination
Solubility & stability profiling
Degradation mechanism studies
Excipient compatibility screening
Formulation Development
Dosage form selection
Drug-excipient compatibility studies
Custom & formal ICH shelf-life evaluation
Controlled and modified release design
Process feasibility and optimization
Prototype preparation
Analytical Testing & Validation
Robust analytical method development & validation
Stability indicating assays
Impurity profile characterization
Custom & ICH stability & compatibility evaluations
Execution of cGMP release testing
Manufacturing Enablement
Pilot plant facilities for non-GMP manufacturing
Process development, scale up, and tech transfer
Manufacturing oversight
CMO identification, inspection, and qualification
More Than Consulting. More Than A Testing Lab.
We are a full-service partner to successfully advance your program.
Our scientists are available to provide insight on service and partnership opportunities. Our team of technical experts provide exceptional pharmaceutical formulation services for a variety of dosage forms. Reach out to discuss your current challenges today!
Why Choose CMC Pharma?
Unlike Traditional CDMOs, We Are Not Tied to Specific Technologies or Dosage Forms
Senior staff with 20+ Years of CMC and Regulatory Experience
Track Record of IND, NDA, and ANDA Success
Trusted by Biotechs, CMOs, Mid-Sized Pharma, and the U.S. Government
Scientific Rigor + Regulatory Insight = Better Outcomes
Fast, Responsive, Confidential Support
Nimble and Able to Help in Any Capacity
With a focus on small molecules, we are highly experienced with traditional dosage forms and novel, long-acting formulations.
Your Application, Our Experience
With decades of specialized pharmaceutical research and development under our belt, we engineer advanced drug formulation and delivery solutions that enable breakthrough therapies across diverse clinical landscapes.
Traditional Formulations
Oral tablets
Hard & Soft Gelatin Capsules
Injectable solutions
Immediate release formats
Advanced Drug Delivery Systems
Controlled Release Formulations
Sustained Release Technologies
In-Situ Forming Gels
Polymeric Drug Delivery Platforms
Complex Suspension Technologies
Therapeutic Areas
Oncology
Cardiovascular & Circulatory Medicine
Neuroscience & Mental Health
Endocrinology & Metabolic Diseases
Orthopedic & Anti-Inflammatory
Infectious Diseases & Immunology
Animal health
And More
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