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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
us. |
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| Product Safety Assessment |
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At Robin Guy Consulting, LLC, we provide clients
in the pharmaceutical, biologic, biotechnology, device, food additive,
food ingredient
and dietary supplement industries with toxicology and product
safety assessment guidance through preclinical and clinical
testing. Our clients are also interested in acquiring preclinical
safety and toxicology information potentially leading
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 review license candidates and perform due diligence audits
as well.
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| Preclinical Toxicology and
Safety Studies |
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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).
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. |
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| Regulatory Submissions and
Compliance |
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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 are available as members of GRAS Expert Panels and are able to assemble a
complete Expert Panel. 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. 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. |
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| GLP Audits |
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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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| Toxicology Review |
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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. |
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| Staff Training |
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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
and one for GLP trainers. In addition, special GLP training courses are available for the universities and the small laboratory.
Learn more about our training courses |
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| Project Management |
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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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| Other Services |
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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 |
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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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