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Robin Guy Consulting,
LLC is a full service company providing a wide range
of services, most of which are described below. Our uniqueness
ensures a close working relationship
with all our clients and gives every project the intense individual
focus it deserves.
If you have any questions, or would like
a more detailed description and clarification of our preclinical,
clinical
and toxicology consultant services, feel free to contact
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Regulatory Submissions
We are a full service company;
therefore, we prepare individual sections or entire packages for US and
worldwide regulatory submissions for potential pharmaceuticals, food ingredients
and medical devices.
Toxicology summary preparation is a specialty at Robin Guy Consulting, LLC.
We prepare toxicology, pharmacology and pharmacokinetic components for regulatory submissions. These regulatory submissions include IND (Section 8), IND annual reports, NDA, Investigational Device Exemption (IDE), 510(k) Premarket Notifications and Premarket Approval (PMA), clinical trial application and new drug submission (TPD, Health Canada), FAP, GRAS dossiers (including self-determinations) to the FDA and ex-US agencies. Our experts are available to attend ex-US and FDA meetings.
We will investigate and provide guidance for FDA GLP, FDA Redbook and ICH guideline compliance. Robin Guy Consulting, LLC will also perform qualification of data for Japanese submissions. We are available as members of GRAS Expert Panels and are able to assemble a complete Expert Panel. MSDS preparation is also a service we provide.
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Product Safety Assessment & Toxicology Reviews
We provide clients with toxicology and product safety assessment guidance through preclinical and clinical testing. Our clients are also interested in acquiring preclinical safety and toxicology information which potentially leads to product commercialization or acquisition.
We work with clients in the evaluation and interpretation of the safety of existing and potential products, metabolites, degradants impurities and intermediates. We have considerable experience with the safety assessment of small and large molecules, nanoparticles and nanomaterials, as well as botanicals.
In addition, toxicology summaries may be prepared for potential products. These summaries can be used as part of a clinical protocol submitted to an Institutional Review Board (IRB), for inclusion in Investigator's Brochures (IB) and for regulatory submissions, in addition to management and investor presentations.
We perform scientific literature searches, review toxicology literature, publications (public and internal documentation) and toxicology study data to generate position or white papers, study reports, and manuscripts or abstracts for publication and for litigation support. In addition, services are provided for peer review of study reports, toxicology or related papers, manuscripts, submissions, etc. We also evaluate the safety of products obtained through manufacturing process changes. We review license candidates and perform due diligence audits as well.
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Preclinical Toxicology and Safety Studies & Project
Management
We effectively design protocols, initiate, monitor and report GLP and range-finding preclinical studies. If requested, we place studies with a reliable worldwide network of contract research laboratories (contract research organizations, CROs).
Our vast experience is utilized in monitoring preclinical animal studies, including general toxicology (acute to repeated dose), carcinogenicity (with or without in utero phase), reproductive toxicology, teratology, in vitro and in vivo genetic toxicology and safety pharmacology. Services are also available for auditing and reviewing studies conducted internally or at outside laboratories (Quality Assurance Audits and Reports) by a RQAP-GLP professional (GLP certification). Clients may also request laboratory GLP facility audits.
Robin Guy Consulting, LLC also is available to provide a leadership role on project management teams in evaluating and interpreting the safety of existing and potential products. We present toxicology and other nonclinical data to management of cross functional groups to facilitate critical decisions for the development and commercialization of potential products.
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Good Laboratory Practice (GLP)
Regulatory Compliance
Good Laboratory Practices (GLP) consulting is another specialty at Robin Guy Consulting, LLC. We assist laboratoriy management and personnel in getting their laboratories up to GLP standards. In addition, we prepare standard operating procedures (SOP) for laboratory efficiency and regulatory compliance. We perform GLP study and facility audits, and GLP training for employees and trainers. MSDS preparation is also a service we provide.
We perform GLP audits of preclinical studies and we also conduct GLP facility inspections of laboratories. These may be conducted at an internal laboratory, a university or at a Contract Research Organization (CRO) in the US or worldwide. If requested, quality assurance audits and reports are issued at the conclusion of these audits. Suggestions are also offered for issues that arise during these GLP inspections and audits. Robin Guy is a GLP certified professional (RQAP-GLP).
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Staff Training
Robin Guy Consulting can also provide your company with employee training. Topics include: food additive and pharmaceutical development processes, and IND, NDA, CTD and GLP training. The GLP training is on two levels, one for study-related personnel (refresher and intensive courses) and one for GLP trainers. In addition, special GLP training courses are available for the universities and the small laboratory.
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REACH Toxicology Consulting
REACH is
a complex European Community Regulation on chemicals and their safe
use (EC
1907/2006). It deals with the Registration, Evaluation, Authorization
and Restriction of Chemical substances.
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“F-Value” Assessments
Pursuant to the POISON PREVENTION PACKAGING ACT OF 1970, as enforced through the CONSUMER PRODUCT SAFETY COMMISSION, we review data on your product to determine the “F-Value”, or the maximum number of units of the product to comply with Child-Resistant Testing Requirements for unit dose packaging. We conduct F-value assessments to determine unit packaging for pharmaceuticals, dietary supplements, etc.
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Fraud Vulnerability Assessment
We work with you and your team to perform fraud vulnerability assessments. The
assessments are meant to cover GLP-regulated departments. These
can be proactive assessments, or reactive assessments as mandated by the
courts or a regulatory authority.
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Other Services
Through our team of professionals, we provide expertise
in CMC. This expertise includes preformulations, formulated delivery systems,
solubilized test systems, bioavailability enhancement through formulations,
development of stable formulation of actives from preclinical to clinical
trails and assessment of cGMP manufacturing through commercialization.
We also provide regulatory, clinical, statistical, and pathology expertise
to produce a complete regulatory package.
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Confidentiality
Robin Guy Consulting, LLC can assure clients absolute confidentiality.
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Home | Services | Background | Contact
GLP Training Division
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e-mail:
rcg@robinguy.com
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