Accelerate Your Drug Product from Bench to Commercial Scale with DSI’s Expert Guidance
At DSI, we provide comprehensive drug product development and manufacturing support to help biotech and pharmaceutical companies successfully transition from early-stage formulation to commercial manufacturing. With expert-driven strategies, hands-on support, and deep regulatory expertise, we optimize your drug product development to enhance efficiency, ensure compliance, and reduce time-to-market.
We specialize in formulation development, process scale-up, technology transfers, manufacturing oversight, and regulatory CMC submissions—helping our clients avoid costly setbacks and ensure product quality from preclinical stages to commercialization.
Comprehensive Drug Product Development Services
Strategic Formulation Development & Optimization
Developing a safe, effective, and scalable drug product requires robust formulation strategies and early risk mitigation. DSI's expert formulators and process engineers ensure your drug product is optimized for stability, bioavailability, and regulatory compliance.
- Oral Solid Dosage Forms (Tablets & Capsules) – Development of immediate, controlled, and extended-release formulations.
- Oral Liquids & Suspensions – Expertise in solutions, suspensions, and functional coatings for improved bioavailability.
- Abuse-Deterrent & DEA Scheduled Products – Advanced formulation techniques to comply with controlled substance regulations.
- Pediatric & Patient-Centric Formulations – Taste-masking, chewables, orally disintegrating tablets (ODTs), powders, and liquids tailored for pediatric and geriatric populations.
- Topical & Transdermal Drug Delivery – Development of creams, gels, patches, and transdermal systems for targeted drug release.
Sterile Drug Product Development
- Pre-Filled Syringes & Vial Formulations – Small & large molecule formulations optimized for sterility, stability, and safety.
- Ophthalmic Drug Development – Sterile liquid and suspension-based ophthalmic formulations.
- Suspensions & Viscous Solutions – Expertise in rheology, particle size control, and homogeneity.
- Advanced Cell & Gene Therapies – Support for Car-T, stem cell, and viral vector-based therapies.
- Aseptic Processing & Validation – Guidance on sterile manufacturing, facility design, and process validation.
Manufacturing & Process Development Support
Scaling up from laboratory-scale production to full-scale manufacturing requires technical expertise and regulatory oversight. DSI provides manufacturing support, CDMO selection, and process optimization to ensure cost-effective and compliant production.
Technology Transfer & Process Scale-Up
- Seamless Tech Transfers – Manage process transfer from R&D to CDMOs and commercial-scale production.
- CDMO Selection & Oversight – Identify, audit, and manage contract manufacturers to ensure quality, efficiency, and compliance.
- GMP & cGMP Manufacturing Support – Ensure compliance with FDA, EMA, and global regulatory agencies for clinical and commercial batches.
- Process Validation & Scale-Up – Develop and validate robust, scalable, and reproducible manufacturing processes.
- Risk-Based Process Development – Implement FMEA (Failure Mode and Effects Analysis) and risk assessments to identify and mitigate process risks.
On-Site Manufacturing Support & Due Diligence
- “Person-in-Plant” Support – Provide on-site monitoring of critical manufacturing operations, validation studies, and regulatory inspections.
- Process Optimization & CAPA Remediation – Address deviation investigations, root cause analysis, and process capability improvements.
- Due Diligence for Mergers & Acquisitions – Conduct facility audits and manufacturing asset evaluations for investment risk assessment.
Regulatory CMC Support for Drug Product Submissions
Navigating the complex CMC regulatory landscape requires a well-structured submission strategy. DSI ensures compliance with evolving regulatory expectations while preparing robust CMC submission packages.
- IND/NDA/BLA/ANDA/MAA CMC Authoring – Develop and compile regulatory-compliant CMC documentation.
- Pharmaceutical Development Reports (PDRs) – Document formulation, manufacturing, stability, and control strategies for regulatory submissions.
- Supply Chain & Raw Material Compliance – Ensure compliance with adulteration risk assessments (melamine, nitrosamine, BSE, TSE) and packaging serialization.
- Pre-Approval Inspection (PAI) Readiness – Conduct mock regulatory audits to ensure successful facility inspections.
- Regulatory Strategy & Agency Interactions – Prepare for pre-IND, EOP2, pre-NDA, and post-approval agency meetings.
Why Choose DSI for Drug Product Development?
✓ Hands-On Expertise in Drug Formulation & Scale-Up
Our seasoned pharmaceutical scientists and process engineers provide direct, hands-on support in drug formulation, scale-up, and manufacturing oversight.
✓ Regulatory Excellence & Compliance Strategy
With successful NDA, BLA, ANDA, and MAA approvals, we ensure your CMC submissions meet global regulatory standards.
✓ Streamlined CDMO Management & Manufacturing Oversight
We help clients identify, audit, and manage CDMOs to prevent delays, reduce costs, and ensure consistent product quality.
✓ Flexibility & Customizable Support
Whether you need early-stage development assistance, regulatory filing support, or commercial-scale manufacturing oversight, DSI provides tailored solutions to meet your unique needs.
Partner with DSI to Streamline Your Drug Product Development
Ensure formulation success, optimize manufacturing, and accelerate regulatory approvals with DSI’s expert drug product consulting services.
Contact us today to discuss how DSI can help you bring your drug product from concept to commercialization efficiently and compliantly.
