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Introductory Consultation
Dedicated to You
From coast to coast, pharmaceutical companies are benefiting from this and other services. It’s time to accelerate your business, and Clearview Pharma Solutions, LLC is here to give you the tools you need in order to succeed.
Strategic Planning Session
Committed to Success
Get focused on direction over the next years, how to get there and how to define success. Make better, more informed business decisions for your target drug candidates and commercial products. Ready to get started? Book this service today to discover what positive change really feels like.
Business models
Paving The Way for Success
Learn more about the two types of consulting retainers that Clearview Pharma Solutions, LLC can offer to clients: Pay for Work retainer and Pay for Access retainer. The choice of consulting retainer depends whether the client has an ongoing project with defined deliverables, or needs to solve unforeseen problems on an ongoing base. Read about the the two types of consulting retainer and decide which one better fits your needs to get started.
Pay for Work Retainer
The Pay for Work retainer model provides ongoing work for clients on a monthly basis for a period of time driven by the project needs. This model is the same as a Contract Work based on the number of hours spent. The consultant is paid on a monthly basis, for 6 or 12 months that can be renewed based on client needs. The monthly fee is based on the project deliverables and is agreed upon between the parties in a signed contract.
Pay for Access Retainer
The Pay for Access retainer model provides access to knowledge, experience and expertise of the consultant on a monthly basis, for 6 or 12 months at a fixed monthly fee that can be renewed based on client needs. The client is not paying for specific upfront deliverables rather, is paying to be able to access the consultant expertise on different projects. The consultant will consistently support the client's business and help with any of the challenges that might come up and is agreed upon in a signed contract.
Expertise
Small molecules and Biologics
We offer full cycle of drug development: drug substance/product stability, impurity identification, strategies for long-term formulation development of drug candidates and commercial products; IND and NDA/BLA submissions, FDA complete response letters, CMC sections on analytical method development, validation/transfer and stability assessment, physicochemical characterization, and structural elucidation of degradation products; Forced degradation study protocol to meet FDA, EME and ANVISA regulations.
Due diligence, assess potential investments for pharma/biotech companies and financial investment/advisory firms.
Innovation strategy.
Preformulation
Preformulation for drug candidate selection in Early Development
Physicochemical characterization and developability assessment
Salts and polymorphs
Preformulation for product design in Early Development
pH-Solubility profile
pH-Rate profile
Forced degradation studies to meet FDA, EME and ANVISA regulations
Identification of degradation products
Preformulation for Excipients and Biopharmaceutical Support in Formulation Development
Drug - excipient compatibility
Formulation
Formulation for Early Development
Formulation design and troubleshooting
Stability Studies for Formulation Development
Stressed stability, long term, and accelerated stability
Cause of instability
Formulation for Late Development
Impurities from excipients
Functional excipients
Novel excipients
Life cycle management
Analytical Development
Analytical method development for small molecules and biologics (mono, combo, triple combination API), validation and transfer, device leachables and extractables (L&E).
Small molecules: assay, impurity, content uniformity, dissolution, solid-state characterization, water content, device performance (emitted dose, aPSD), cleaning validation, process analytical technology (PAT), device leachables and extractables.
Biologics: Reversed phase HPLC (RPLC), size exclusion chromatography (SEC), ion exchange chromatography (IEX), capillary zone electrophoresis (CZE), capillary isoelectric focusing (cIEF), activity assay, dissolution and performance, cleaning validation.
Strategic long-term plan for formulation development
Phase 1: Forced degradation, stability indicating analytical method, excipients selection and compatibility, cause of instability.
Phase 2: Identification (ID) of major degradation products, elucidation of the degradation mechanism(s).
Phase 3: Formulation improvement, impact assessment, impurity ID (continue), genotoxic alerts.
Regulatory filing
CMC sections for IND, NDA, and BLA submissions
FDA CMC Briefing Book, protein characterization plan
FDA complete response letters
FDA, EME and ANVISA regulations.
Due diligence and Innovation Strategy
Due diligence
Assess potential investments for
- pharma/biotech companies
- financial investment/advisory firms.
Innovation strategy
Are you interested in receiving pharmaceutical consulting services?
Contact Us
Please fill out this form and I will respond by email. Alternatively, you can email us at andrei@clearviewpharmallc.com