Comprehensive API Development from Early-Stage to Commercialization
At DSI, we do more than advise—we do hands-on work to ensure the success of your Active Pharmaceutical Ingredient (API) program. Our team brings 175+ years of combined experience in small molecule and peptide API development, process scale-up, regulatory strategy, and global CMC compliance.
From early-stage route selection to commercial manufacturing and API regulatory readiness, we provide strategic technical oversight, contract manufacturer selection, and regulatory filing support. Our international network of CMOs/CDMOs ensures that your API development and manufacturing process is efficient, scalable, and compliant with FDA, EMA, and ICH guidelines.
End-to-End API Development & Manufacturing Support
API Process Selection, Scale-Up & Manufacturing Implementation
Developing a robust API manufacturing process requires careful selection, optimization, and alignment with regulatory expectations. Our CMC experts ensure that your API process is scalable, cost-efficient, and regulatory-compliant.
- Strategic CMO/CDMO Selection – Utilize DSI’s extensive CMO network to identify the right partner based on project needs, location, and budget.
- Process Development & Optimization – We guide chemical process development from initial lab feasibility to full-scale commercial manufacturing.
- Scalability & Cost Optimization – We identify cost-effective processes that ensure robust quality control while maintaining commercial viability.
- Regulatory-Ready Process Design – Our API process strategies align with ICH guidelines, ensuring a strong regulatory submission.
- Technology Transfer Support – Seamless lab-to-plant and plant-to-plant technology transfer to ensure efficient API scale-up.
API Manufacturing Oversight & Troubleshooting
Scaling up API production presents unique challenges, and DSI’s hands-on experts help navigate manufacturing hurdles, mitigate risks, and ensure compliance.
- On-Site Oversight & CMO Management – We provide real-time support during manufacturing, batch execution, and troubleshooting.
- Contract Manufacturer Selection & Due Diligence – Assistance in identifying, auditing, and selecting the right CMO/CDMO partners.
- Deviation Investigation & CAPA Implementation – Address unexpected batch failures with data-driven root cause analysis and corrective/preventive actions (CAPAs).
- Process Validation & GMP Readiness – Ensure cGMP-compliant manufacturing from Phase 1 through commercial launch.
- Supply Chain Security & Business Continuity Planning – We assess risks and develop strategies to maintain API supply security.
Regulatory Affairs & API Filing Support
Regulatory compliance is crucial at every stage of API development. DSI ensures that your API meets evolving FDA, EMA, and ICH requirements while keeping your CMC sections aligned with submission expectations.
- Regulatory Gap Analysis & Readiness Assessment – Identify and close gaps in API CMC compliance before regulatory milestones.
- Regulatory Starting Material Justification – Develop and defend regulatory starting material (RSM) selection to streamline agency approvals
- IND, NDA, BLA, & IMPD API Sections – Author, review, and optimize API Module 3 (CMC) documentation to ensure smooth regulatory review.
- Agency Meeting Support (FDA, EMA, MHRA, etc.) – Prepare for pre-IND, EOP2, pre-NDA, and Type C meetings to accelerate approvals.
- CMC Change Management & Comparability Reports – Strategize significant CMC changes, author comparability protocols, and manage global regulatory filings.
Why Choose DSI for API Development?
We Solve Problems, Not Just Advise – Our hands-on experts work directly with your CDMOs to troubleshoot API development issues and regulatory roadblocks.
Global CMO/CDMO Network – We connect you with the right contract manufacturing partners to ensure cost-effective, high-quality API production.
Regulatory-Driven Approach – We align API manufacturing, documentation, and submission strategies with FDA, EMA, and ICH requirements.
End-to-End Lifecycle Support – From early-stage route selection to commercial process validation, DSI ensures your API program remains on track and in compliance.
Proven Track Record – Our API consultants have successfully led NDAs, BLAs, ANDAs, and global marketing approvals, ensuring that clients meet critical regulatory milestones.
Partner with DSI for API Development Excellence
Accelerate your API development, scale-up, and regulatory submission with DSI’s industry-leading API experts.
Contact us today to discuss how DSI can support your API manufacturing and regulatory strategy.
