EXTENSIVE EXPERIENCE IN PROVIDING REGULATORY, DRUG DEVELOPMENT AND QUALITY SYSTEMS CONSULTING SERVICES
DSI is a pharmaceutical consulting company with extensive experience in providing CMC regulatory, drug development consulting services and products to developers and manufacturers of new drug products.
DSI is proud to offer more than CMC consulting and regulatory support to our clients – once we are on-board, we view ourselves as your partner.
Our mission is to provide guidance and value at every step of the drug development process, from conception to clinical trials through commercialization
.Regardless of the stage of your product’s development, the DSI team brings the technical expertise and industry experience necessary to step in and provide hands-on support to your team.
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.
Drug Substance Development Expertise
- Synthetic process and characterization
- Drug substance process development from bench to full scale
- Regulatory starting material selection/justification
- Manufacturing support for GMP clinical supplies, registration, and validation.
- Impurity control strategy including characterization, fate of impurities and purging studies
- Identification of critical process parameters, process control strategy
- Contract Manufacturing Organization evaluation and qualification
- Reprocessing or rework strategies
- Nitrosamine and elemental impurity risk assessments
- Subject matter expert support for regulatory filings and regulatory meetings
Drug Product Development Expertise
- Drug product expertise in liquid and solid oral dosage forms, sterile liquids for injection, suspensions, liposomes, lyophilized powders and combination products.
- Contract Manufacturing Selection and Qualification
- Process characterization (mixing, blending, tablet compression, liquid filling, hold time studies packaging)
- Container closure and packaging development/qualification, container closure integrity
- Aseptic injectable or ophthalmic process qualification (filter validation, lyophilization qualification, environmental and manufacturing controls for aseptic manufacturing)
- Microbial quality assessment (microbial controls for non-sterile dosage forms, sterility assurance for injectables/ophthalmics, endotoxin control)
- Extractable and Leachable assessment
- Clinical Supplies labelling, distribution and tracking
- Shipping Validation
- Expert support for regulatory filings and meetings.
Analytical Methods and Quality
- Development of stability indicating methods for release and stability of drug products and drug substances
- Reference Standard qualification
- Validation of regulatory methods per ICH and compendial requirements
- Dissolution method development and validation
- Excipient methods qualification and vendor qualification
- Specification setting and justification
- Container Closure Integrity Testing
- Stability protocols and data interpretation/shelf-life justification for clinical, registration and commercial programs
- Stress studies including photostability, forced degradation and temperature cycling.
- Contract Laboratory selection and qualification, method transfers
Regulatory Strategy
- Author Investigational New Drug Filings Phase 1 through Phase III (IND and IMPD)
- Author and review New Drug Application/Marketing Authorization Application Modules 2 and 3.
- Agency Meetings technical and regulatory support
- Agency Query response
- Application publishing services
Post-Market Approval
- Validation and Scale up
- Post Approval Changes
- Annual reporting
