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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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