Wyatt Pharma Consulting
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Services

Design. Explore. Solve.

Areas of Expertise and Services Available

 

Preformulation

Expertise in conducting, evaluating results and determining a path for development based on the following physical and chemical techniques and properties:

  • Particle Size/Morphology

  • Moisture Sorption

  • Solubility

  • Exipient Interactions / Compatibility

  • Melting Point

  • Glass Transition

  • Crystallinity

  • Polymorphism

  • Chemical and Physical Stability

INTELLECTUAL PROPERTY

With extensive experience in drafting, prosecuting and defending patents, Wyatt Pharma Consultants can improve and extend the life cycle of your product with the following services:

  • Product Development to Gain IP

  • Patent Landscape Review and Guidance on Development Path

  • Guidance on Technical Specification and Claims

  • Patent Litigation Support

Drug Substance

Never underestimate the importance of drug substance selection and characterization to successful drug product development. Wyatt Pharma Consulting an assist with the following services:

  • Salt selection

  • Potency Determination

  • Reference Standard Qualification

  • pH-solubility, pH-stability

  • Physical and Chemical Characterization of Drug Substance

  • Assistance in Setting Drug Substance Specifications

  • Drug Substance Vendor Selection and Management

Formulation Development

Experience in formulating oral solid dose, softgels, liquids, semisolids, inhalation, nasal, sterile and topical dosage forms. Services include:

  • DrugProductVendor Selection and Management, Clinical/Commercial

  • Excipient selection and level setting

  • Flow optimization/characterization

  • Pre-clinical dosage form design

  • Clinical, Preclinical and Toxicology Formulation Design

  • Excipient Optimization for Stability and Processability

  • Short-term Stability Studies

  • Full ICH Stability on Candidate Formulations

CMC Regulatory

With both NDAs and INDs under our belt, we will be able to assist with:

  • CMC Regulatory Risk Assessment

  • Drafting of Regulatory Filings (IND, IMPD, NDA, ANDA)

  • Review of Regulatory Filings (IND, IMPD, NDA, ANDA)

  • Guidance on Regulatory Path and Studies Needed

  • Response to Regulatory Review Comments

  • Regulatory In-Person Meetings and Defense

Process Development

With hands on experience in the following technologies we will be able to guide prototype process development, scale-up, technology transfer and process validation:

  • Blending Technologies

  • Fluid Bed Granulation

  • Fluid Bed Wurster Coating

  • High Shear Granulation

  • Dry Granulation/Roller Compaction

  • Single layer and Multilayer Compression

  • Liquid and Powder Encapsulation

  • Functional and Active Pan Coating

  • Oral Osmotic Processes

  • Hot Melt Extrusion

  • Spray Drying

Analytical Development

Full service phase appropriate analytical development and validation services, specification setting and justification, protocol generation and review and stability tracking and trending for drug substance and drug product using the following techniques:

  • Assay and Impurities by HPLC, GC and UPLC

  • Residual Solvents by GC

  • Dissolution analysis by USP I, II, III, IV, VII apparatus

  • Dissolution of delayed and modified release dosage forms

  • Dissolution of poorly soluble compounds

  • Water content analysis by KF and LOD

  • Elemental impurities by ICP, ICP-MS

  • Microbial limits testing