Clearview Pharma Solutions LLC

Success Begins with a Single Choice

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Pharmaceutical consulting

Work Retainer

Access Retainer

Join other satisfied clients to gain the confidence and the tools you need for success in achieving your strategic objectives. The ability to reach your goals depends on the choices you make today. Just click below to get started.

Business Meeting

Introductory Consultation

Dedicated to You

From coast to coast, countless clients 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.

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Business Meeting

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. 

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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.

Client 8

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 without the monthly payment fluctuation 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.

Client 2

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 that can be renewed based on client needs. The client is not paying for specific 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, 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 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?

Reach out today

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