NEW EXPANDED SERVICES!
- Degradation Predictions using Lhasa’s Zeneth software
- Forced Degradation Critical Analyses for drugs to be submitted to Brazil’s ANVISA (RDC 53/15 legislation)
- N-Nitroso / N-Nitrosamine Impurities and Risk Assessments for the Formulated Product
-
Solid State Characterization / Form Control
-
Salt and Polymorph Selection
-
Disproportionation
-
Method Validation and Transfer
-
Specification Development
-
Peptide and Protein Therapeutics
Stress Testing / Forced Degradation Studies
- Overall Strategy
- Design, Execution, and Interpretation of studies
- Leveraging for Analytical Method Development
- Leveraging for Mechanistic Investigations
- Regulatory Module Authoring / Review
Photostability / Photochemistry
- Design, Execution, and Interpretation of ICH Q1B Studies
- Forced degradation
- Confirmatory
- Patient In-Use Studies
- Photochemistry / Mechanistic Investigations
Analytical and Mutagenic Impurity Control Strategies
- Design / Development of Analytical Methods
- “Ordinary” Impurities
- Genotoxic / Mutagenic Impurities
- Trouble-Shooting Analytical Methods
- Solving Analytical Artifact Issues
- Leveraging Forced Degradation Studies
- Process Impurity Discovery, Structure Elucidation, and Mechanistic Chemistry
- Analytical Method Development
Chemical, Physical, and Environmental Stability / Degradation
-
Degradation Chemistry
Degradation Forecasting
- Forecasts intended to predict degradation chemistry issues
- In Silico: Predictions Using Zeneth™ Chemical Degradation Software
- In Cerebro: Predictions Using Chemistry Knowledge to Predict
- Degradation Product Identification / Structure Elucidation
- Degradation Pathway Determination
- Mechanistic Investigations
- Kinetics
- Degradation reaction mechanisms
- Mass balance investigations
- Literature precedence / literature searching
Stability
- Storage and Distribution Considerations
- Patient In-Use Considerations
- Environmental Degradation / Fate
- Physical Stability / Changes related to:
- Processing
- Formulation
- Aging
- Forecasts intended to predict degradation chemistry issues
Scientific Staff Development
- Seminars / Training
- Technical Writing Skills
- Developing an Internal / External Sphere of Influence
- Scientific Manuscripts and Presentations
- Developing the manuscript / presentation
- Authoring, assistance with authoring, proofing
Global Regulatory Submissions and Issues
- Authoring / Review of Regulatory Submissions
- Responding to Regulatory Agency Questions
Pharmaceutical CM&C Due Diligence Assessments
- In-licensing and Out-licensing
- Analysis of Analytical / Formulation aspects of potential licensing candidates
- Available for global travel, as needed.
Formulation Design and Stabilization
- Drug-Excipient Compatibility Studies
- Drug-Excipient Interactions
- Formulation-Induced Instability
Legal / Expert Witness / Patent Disputes
- Experience with both depositions and trial testimony as an Expert Witness
Contracts have been established and services provided to more than 60 pharma / biotech / agriscience companies in the last 5 years!
