DSI offers one-stop, full-service CMC experience to the development and regulation of drugs and biologics to emerging pharmaceutical and biopharmaceutical companies.
For pharmaceutical and biopharmceutical companies with products in development, DSI is the CMC and regulatory affairs company to partner with.
Our team of specialized CMC consultants has real-world experience.
DSI specializes in providing regulatory, product development and quality systems consulting services. Our staff consists of experts in quality management, regulatory affairs, product manufacturing and testing, statistics, and GMP, GCP regulatory compliance. We offer consulting services and regulatory support based on a full understanding of FDA regulatory expectations and policies.
DSI can drive your product development program from start to finish. Or, fill in-house CMC expertise gaps on a project basis.
We have expertise with all regulated therapeutic dosage forms.
|Protein Therapeutic Specialties||Small Molecules||Dosage Forms|
|• Biosimiliars||• New Chemical Entities (505(b)(1))||• Solid Orals and Liquid|
|• Monoclonal Antibodies||• Compendial Actives (505(b)(2))||• Parenteral Injections (liquid and lyo)|
|• Recombinant Proteins||• Generics (505(j))||• Inhalation|
|• Protein/Drug Conjugates||• Cytokines||• Transdermal Patches|
|• Hormone peptides||• Peptides||• Gels|
- Overcoming drug development challenges?
- Scaling up your process?
- Selecting and managing your vendors?
- Establishing a document management system?
- Determining your regulatory strategy?
- Performing supplier audits?
- Generating your NDA/BLA?
CMC REGULATORY AFFAIRS
- The right filing strategy
- The right briefing documents and agency questions
- The right investigational and marketing submissions
- Customizable document templates to reduce regulatory risk
ACTIONABLE STRATEGIES, EXECUTION AND MANAGEMENT.
A streamlined, more efficient path from drug development through approval.