Consulting Services

The first, all-important step in transforming a molecule into a medicine is to select the solid form that will be produced as a drug substance, formulated into a drug product, and for solid oral dosage forms, delivered to the patient. Our mission is to help you get it right, preferably the first time.

We can help:

We do this by:

find commercially-viable crystal forms for your drug substance and drug product

select the best form to meet your performance criteria

guide you in how to make, use, and protect your crystal form IP

troubleshoot problems along the way

scoping out your problem or project need to determine if / how we can help

joining your team

helping you build your team of consultants, CROs and other service providers

providing referrals as and when needed

Scientific consulting services

SOLID FORM SCREENING

We design experimental protocols that are fit for purpose, phase appropriate, material sparing, and tailored to the attributes of the drug molecule to find as many crystal forms as possible.

SOLID-STATE CHARACTERIZATION

We devise characterization strategies (methods, measurement conditions) to identify solid forms and establish their phase stability relationships and other key properties.

SOLID FORM SELECTION

We recommend the solid form best suited for a commercial drug product based on a comprehensive assessment of available data.

SOLUBILITY ENABLING SOLID FORMS

We enable toxicology studies through the design and execution of intelligent, material sparing screens for salts, cocrystals and amorphous forms.

SOLID FORM CONTROL

We provide design criteria to achieve polymorph selectivity in crystallization processes and recommendations to maintain the form throughout formulation processing and storage.

in silico SOLID FORM design

We leverage cutting edge modeling and simulation methodology, including crystal structure prediction, and solid form informatics tools to assess polymorph risk.

REGULATORY SUBMISSIONS

We review CM&C sections of regulatory documents to ensure preparedness for submission and work with you to field agency questions.

PROBLEM SOLVING

We expertly troubleshoot polymorphism and crystallization issues to identify solutions based on fundamental scientific understanding.

legal consulting services

We comprehensively analyze and interpret your solid-state form data and recommend additional data collection, when needed.

We assess the patentability of your crystal form IP by reviewing the patent landscape and the prior art (literature precedence).

We help you to structure your claims for crystal form patents and work with you to respond to patent office rejections.

We render an expert scientific opinion on patent infringement based on available data, recommending further testing, if needed.

We serve as a fact witness to support the prosecution of patents.


TRAINING SERVICES

SEMINARS / TRAINING MODULES

Intro to pharmaceutical solids

Crystallization basics

Optimizing material properties

Solid form screening I – Best practices

Solid form screening II – Pushing the envelope

Physical characterization of pharmaceutical solids

Digital design of pharmaceutical solids

Crystal form patents 101

Skills development

Technical writing (reviewing, proofing)

Scientific presentations with staying power

career coaching

Scientific / technical leadership

Career advice

Mentorship

Ready to start a new project with SuRE Pharma Consulting, LLC?

SuRE Pharma Consulting, LLC

7163 Whitestown Parkway – Suite 305

Zionsville, IN 46075

+1 (317) 260-1708

susan@surepharmaconsulting.com

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