In the drug development world, especially for peptide-based therapeutics, one of the most important steps is generating strong, reliable data for regulatory approvals. At ResolveMass Laboratories, we provide expert peptide characterization for IND and NDA submissions. Our lab helps you move faster without missing any regulatory detail.
Whether you are preparing your first IND (Investigational New Drug application) or finalizing an NDA (New Drug Application), we offer advanced testing that confirms your peptide product is safe, stable, and ready for the next step. We work closely with biotech and pharma companies across North America to meet tight timelines and stay ahead of regulatory expectations.
What Does Peptide Characterization for IND and NDA Involve?
Peptide characterization means performing a group of laboratory tests to confirm a peptide drug’s identity, quality, and behavior. These tests check for things like purity, structure, sequence, degradation, and stability. Regulatory agencies such as the FDA and Health Canada require this data in both IND and NDA submissions.
We verify the full molecular structure of your peptide and examine how it reacts under different storage and stress conditions. By analyzing how peptides break down and identifying possible impurities, we help you avoid issues during review and ensure consistent performance across production batches. This gives regulators confidence in your product’s safety and reliability.
Why Is Peptide Characterization Critical for IND and NDA Approvals?
When submitting peptide drugs for approval, your documentation must show that the product is well understood and safe. Regulatory delays often happen because of missing or weak data related to product characterization. That’s why this step is essential and must be done with care.
At the IND stage, the focus is on proving early safety, consistency between batches, and the absence of harmful or unknown compounds. For the NDA stage, your data must go deeper. You’ll need validated methods, long-term stability studies, and precise product specifications that show your peptide will remain stable and safe during its shelf life.
With ResolveMass, you don’t have to navigate these steps alone. We support both early development and final approval phases with a well-planned, structured approach that speeds up your submission process and reduces risk.
To meet these requirements, ResolveMass Laboratories’ peptide characterization service in Canada integrates advanced MS, HPLC, and bioanalytical platforms optimized for regulatory submissions.
Our Accelerated Workflow for Peptide Characterization
We have created a fast and efficient workflow to handle peptide characterization for IND and NDA projects. Our process is designed to generate clear, high-quality data in just a few weeks—without sacrificing accuracy or compliance.
🧪 Initial Analysis of the Peptide
We begin with LC-MS/MS testing, which helps us determine the molecular weight and structural profile of the peptide. This early insight lets us flag challenges such as solubility issues or sites that may be prone to chemical modification. Getting this information early helps shape the rest of the testing plan.
🧬 Customized Method Development
Next, we build test methods tailored to your peptide and its development phase. In early stages, we focus on exploratory assays, while later phases require validated, regulatory-grade methods. We ensure a smooth transition from discovery to submission-ready documentation.
⚗️ Mapping Impurities and Degradation Products
We use high-resolution mass spectrometry (HRMS) to detect and identify impurities—whether they come from the manufacturing process or natural degradation over time. These tests are essential to ensure patient safety and comply with regulatory expectations.
🔬 Stability and Forced Degradation Studies
Following ICH Q1A guidelines, we expose the peptide to stress conditions such as heat, light, and varying pH levels. These tests show how your product will behave over time and help predict its shelf life. This is a key part of both IND and NDA filings.
📑 Submission-Ready Reporting and Guidance
Finally, we provide detailed and easy-to-read reports that are formatted for regulatory review, including CMC (Chemistry, Manufacturing, and Controls) sections. Our scientists are also available to answer technical questions or assist with regulatory meetings if needed.
Analytical Techniques Used in Peptide Characterization
To deliver complete and accurate peptide characterization for IND and NDA, we use a set of trusted analytical tools. Each technique plays a specific role in confirming quality, structure, and safety.
- High-Resolution Mass Spectrometry (HRMS): Confirms the peptide’s exact weight and fragmentation patterns to verify identity.
- Reverse-Phase & Ion Exchange HPLC: Measures purity, detects unwanted impurities, and identifies charge-related variants.
- Disulfide Bond Mapping: Confirms proper folding and bond formation in peptides with cysteine residues.
- Peptide Mapping via LC-MS/MS: Validates the full amino acid sequence and identifies post-translational modifications.
- Solubility & Aggregation Testing: Evaluates how the peptide behaves under stress, helping ensure dosage and formulation consistency.
These methods are validated and adapted based on your development stage, making sure the data supports your IND or NDA submission from start to finish.
Explore the full range of peptide characterization services tailored to IND/NDA needs.
Fast Turnaround, Full Compliance, and Trusted Expertise
At ResolveMass, we combine scientific knowledge with regulatory understanding. Our labs operate according to the latest global standards, and we deliver high-quality results quickly—usually in 2 to 6 weeks, depending on complexity.
- GMP-Compliant Operations: All protocols follow Good Manufacturing Practices to ensure traceability and data integrity.
- ALCOA+ Standards: Our reports are complete, accurate, and easy to audit, with full documentation of each test.
- North American Reach: We support companies across Canada, the U.S., and internationally with reliable results and personalized service.
Whether your project is large or small, we treat every peptide with the same level of care and scientific rigor.
We invite you to explore our full suite of peptide characterization services or contact our scientists directly.
📩 Contact Us to get started with your accelerated peptide characterization project.
Why Choose ResolveMass for Your IND or NDA Peptide Testing?
We understand that timelines are tight and approvals are critical. That’s why we’ve made it our mission to provide top-tier peptide characterization for IND and NDA with unmatched speed and attention to detail.
You’ll get:
- A team of skilled scientists who align with your internal development goals
- Phase-specific methods for early research, IND, and NDA stages
- Flexible testing plans that adapt to your timeline and budget
- Detailed reports ready for submission, plus regulatory support if questions arise
By working with us, you gain more than just lab results—you gain a trusted partner in your regulatory journey.
Frequently Asked Questions (FAQs)
Peptide characterization uses techniques like Mass Spectrometry (MS) to confirm molecular weight, HPLC for purity analysis, and NMR spectroscopy for structural confirmation. Amino acid analysis and FTIR are also used to verify composition and bonding. These methods ensure peptides meet regulatory standards for IND and NDA submissions.
Speeding up the characterization process helps you meet key development milestones and submission deadlines. Faster results mean quicker decisions, earlier regulatory filings, and improved chances of success. At ResolveMass, we ensure fast turnaround without sacrificing accuracy or compliance.
Common tests include LC-MS/MS, HPLC, peptide mapping, impurity profiling, disulfide bond analysis, and stability studies. These methods help prove the identity, structure, and behavior of your peptide under different conditions. We adapt the testing strategy based on your peptide’s phase and regulatory needs.
We use advanced tools like high-resolution mass spectrometry (HRMS) and LC-MS/MS to detect and identify impurities in your peptide sample. These may be byproducts from manufacturing or degradation over time. Detecting and characterizing impurities is critical for safety and regulatory approval.
Disulfide mapping checks whether the correct disulfide bonds have formed in peptides that contain cysteine residues. These bonds affect how the peptide folds and functions. Proper mapping ensures the peptide has the intended structure, which is essential for its stability and biological activity.
Yes, we offer both forced degradation studies and long-term ICH-compliant stability testing. These studies reveal how your peptide behaves under stress, like heat or pH changes, and over time. This information is vital for setting shelf-life and ensuring long-term product quality.
Simply contact us with your project scope, and our experts will guide you through the onboarding and analytical planning process.
Conclusion: Secure Your IND or NDA with Expert Peptide Characterization
Getting a peptide drug to market takes more than just good science—it takes the right data, the right testing methods, and the right partner. With ResolveMass Laboratories, your peptide characterization for IND and NDA is in expert hands.
From impurity mapping to disulfide analysis and stability studies, we help you move your product forward with confidence. Our lab combines fast timelines, regulatory know-how, and deep analytical expertise—giving you the edge in today’s competitive biotech space.
🔬 Ready to advance your program?
📞 Connect with our team for a free consultation.
📧 Submit your inquiry and begin your analytical journey.
