At DSI, we are more than just a consulting firm—we are your strategic partner in small-molecule drug development. From early discovery through commercialization, we provide end-to-end Chemistry, Manufacturing, and Controls (CMC) regulatory consulting, drug development strategies, and quality system solutions to ensure compliance and accelerate time to market. Whether you are navigating an Investigational New Drug (IND) application, preparing for a New Drug Application (NDA), or managing post-approval changes, our team of seasoned industry experts is here to support you every step of the way.
Our deep expertise covers all facets of small molecule pharmaceutical development, including drug substance (API) process development, drug product formulation, analytical methods, and regulatory strategy—ensuring your product meets global regulatory requirements and reaches patients efficiently and safely.
Knowledge and Hands-on Experience in Hundreds of Successful Applications and Regulatory Submissions
The prerequisite Investigational New Drug Application (IND) spans the full spectrum of the drug development pathway ultimately to the New Drug Application (NDA). Our breadth of experience allows us to develop comprehensive strategies and product development plans to position clients for successful product outcomes and regulatory approvals. For each engagement, we leverage our knowledge and hands-on experience in creating product development pathways and maneuvering, through the relevant nuances, to position our clients for successful outcomes and regulatory approvals.
Regulatory and CMC Consulting for Small Molecule Development
With hands-on experience in hundreds of successful regulatory submissions, our experts guide clients through the intricacies of regulatory strategy, submission preparation, and compliance. We tailor our services to your unique needs, ensuring seamless interactions with the FDA, EMA, and other global health authorities.
Comprehensive Regulatory and CMC Expertise
- Regulatory Strategy and Planning: From pre-IND consultations to NDA/MAA filings, we provide strategic guidance to streamline your regulatory pathway and mitigate risks.
- CMC Regulatory Writing and Submission Support: We author, review, and publish INDs, NDAs, CTDs, IMPDs, and post-approval submissions with precision.
- Agency Engagement & Meeting Support: Our team prepares meeting briefing packages, conducts risk assessments, and provides expert representation during FDA, EMA, and other regulatory interactions.
- Post-Approval CMC Submissions: We manage all aspects of post-market changes, annual reports, and lifecycle management to ensure ongoing compliance.
Drug Substance (API) Development & Manufacturing Support
A robust drug substance development strategy is essential for ensuring a high-quality, cost-effective, and scalable manufacturing process. Our expertise spans early-phase development through commercial production, ensuring your API meets stringent regulatory expectations.
Drug Substance Development & Optimization
- Synthetic Process Development & Characterization: We support API process design, from initial feasibility studies to full-scale production, ensuring a scalable and reproducible process.
- Regulatory Starting Material Selection & Justification: Strategic selection and justification to streamline approvals and minimize regulatory hurdles.
- Impurity Profiling & Control Strategy: Development of impurity fate, purge studies, and ICH-compliant control strategies to ensure product safety and quality.
- Manufacturing Support & CMO/CDMO Oversight: Expert evaluation, selection, and qualification of Contract Manufacturing Organizations (CMOs/CDMOs) to ensure GMP-compliant API production.
- Reprocessing & Rework Strategies: Development of regulatory-compliant approaches for managing out-of-specification batches and process deviations.
- Nitrosamine & Elemental Impurity Risk Assessment: Comprehensive risk evaluations and mitigation strategies to ensure regulatory compliance.
Drug Product Development & Formulation Services
DSI provides expert formulation development, process optimization, and manufacturing oversight to ensure the stability, efficacy, and manufacturability of your drug product. We help optimize your formulation and scale-up processes while maintaining compliance with global regulatory expectations.
Comprehensive Drug Product Development Support
- Expertise Across Dosage Forms: We specialize in solid and liquid oral dosage forms, injectables, liposomes, suspensions, and ophthalmic formulations to meet diverse therapeutic needs.
- Process Development & Scale-Up: Optimization of mixing, blending, tablet compression, liquid filling, and lyophilization to support clinical and commercial production.
- Aseptic & Sterile Manufacturing Support: Process validation for injectables, ophthalmics, and biologics, including filter validation and sterility assurance.
- Container Closure & Packaging Development: Evaluation and qualification of primary and secondary packaging materials to ensure stability and regulatory compliance.
- Extractable & Leachable Assessment: Risk assessment and testing strategies to mitigate patient safety risks.
- Clinical Supply Management: Comprehensive support for labeling, distribution, shipping validation, and cold chain logistics.
- Regulatory Filing & Expert Support: Preparation of eCTD Module 3 technical sections, including stability data, manufacturing processes, and quality assurance documentation.
Analytical & Quality Control Solutions
Robust analytical methods and quality control strategies are essential to ensure product consistency, efficacy, and safety throughout development and commercialization.
Analytical & Quality Services
- Stability Indicating Method Development & Validation: Development of ICH-compliant methods for drug substance and product stability testing.
- Reference Standard Qualification & Control Strategy: Establishing and validating reference materials to ensure analytical precision.
- Dissolution Method Development & Validation: Ensuring bioavailability and regulatory compliance through optimized dissolution testing.
- Specification Setting & Justification: Establishment of clinically relevant specifications for release and stability.
- Container Closure Integrity Testing: Verifying container closure systems for leak-proof and sterile integrity.
- Forced Degradation & Stress Testing: Conducting photostability, thermal, and oxidative degradation studies to establish product robustness.
- Contract Laboratory Qualification & Method Transfer: Selecting and qualifying analytical labs and managing method transfer activities to external partners.
Post-Approval & Lifecycle Management
Navigating post-market compliance and regulatory changes is crucial to maintaining product integrity and market competitiveness. DSI provides comprehensive post-approval support to help clients manage product updates, quality improvements, and compliance requirements.
Post-Market Regulatory & CMC Services
- Process Validation & Commercial Scale-Up: Ensuring seamless transition from clinical to commercial-scale manufacturing.
- CMC Variations & Post-Approval Supplements (PAS, CBE, Annual Reports): Supporting regulatory submissions for process changes, site transfers, and formulation updates.
- Ongoing Quality & Compliance Monitoring: Assisting with cGMP audits, CAPA implementation, and supplier oversight.
Why Choose DSI for Small Molecule Development?
Your Partner in Regulatory & CMC Excellence
Industry-Leading Expertise: Our team of 60+ SMEs offers unparalleled expertise across all CMC sub-disciplines, ensuring a phase-appropriate approach to development.
Seamless Project Execution: We provide both strategic consulting and hands-on support, bridging gaps and expediting regulatory approvals.
End-to-End Regulatory Support: From pre-IND planning to NDA submission and post-market compliance, we offer full-spectrum regulatory and CMC solutions.
Proven Success Across Global Markets: Our regulatory experts are well-versed in FDA, EMA, and ICH guidelines, ensuring compliance across regulated regions.
Commitment to Quality & Compliance: We prioritize client collaboration, version control, and compliance-driven project management.
Partner with DSI Today
Empower your small molecule drug development program with DSI’s unmatched regulatory and CMC expertise. Contact us today to discuss how we can accelerate your path to market with tailored, innovative solutions.
