Company Overview Presentation - Peritus Consultants, Inc.

jamaicanabsorbingBiotechnology

Dec 5, 2012 (4 years and 6 months ago)

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1


COMPANY
OVERVIEW

2

Company Overview


Peritus Consultants is a minority/women
-
owned and
operated business that provides specialized consulting
and training for our clients. In the following slides,
you will find a brief description of the company’s
objectives, capabilities and experience.



For additional information, please visit our web site:





www
.
peritusconsultants
.
com


3

About us


Peritus Consultants, Inc.

specializes in a wide
variety of projects ranging from cGMP training to
general facilitation.



The company is a reliable source of customized
business consulting and training services, and has
the capacity to utilize diverse business experience
and technical expertise to tailor services to each
individual client's needs.



Our in
-
house capability provides clients with a

competitive edge and the necessary resources to
remain successful in highly dynamic industries.


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Office Locations

Peritus

Consultants,

Inc
.

is

headquartered

in

Maryland
.


Peritus Consultants, Inc. office

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Mission Statement


Peritus Consultants, Inc.

is dedicated to the
execution of projects that foster science,
technology, engineering and/or education
advancements.



Peritus
, the Latin word meaning expertise,
summarizes the values of professionalism and
dedication that
Peritus Consultants, Inc.

is built
upon, and the quality of work provided to each
and every client.


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The Peritus Team


Dr
.

Antonio

R
.

Moreira


Peritus Consultants, Inc. Board Chairman
and President


Close to 30 years of experience in the
field


10 years senior management experience
in large multinational biotechnology
companies




Extensive experience in R&D, manufacturing,
regulatory affairs, and design and operation of pilot
and large scale CGMP production facilities


Experience with FDA and international regulatory
agencies as an industry representative and as a
consultant to agency experts


7

The Peritus Team


Mrs
.

Cecilia

M
.

Wentzell


Vice President of Peritus
Consultants, Inc.


5 years experience in construction
management




Managed multi
-
million dollar projects in
Connecticut, Florida, and Maryland, including new
construction, interior fit
-
out, historical renovation,
and hi
-
tech facility construction.


Experience in both private and public sector project
management


Currently completing Master of Education Degree


8

Consulting Services


Peritus Consultants, Inc.
provides clients with a
variety of business development and technology
consulting services in the following areas:



Biotechnology

&

Pharmaceutical

Industries


Business

&

Technology

Management


Education

&

Training

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Biotechnology &

Pharmaceutical

Peritus Consultants, Inc.

biotechnology &
pharmaceutical industries consulting
capabilities include:


Upstream & Downstream process
development, optimization & validation;


Design, preparation, and review of documents
in support of CGMP compliance;


Facility design, equipment selection and
qualification, equipment commissioning, and
vendor auditing as related to CGMP
compliance; and


Feasibility assessment studies including facility
construction and new product development.



10



BIOGMP
:

Dr. Moreira led the development of a
CD
-
ROM based training program for workers in
the biotechnology industry on the compliance
aspects of current Good Manufacturing
Practices as regulated by the US FDA.



Bio
-
manufacturing of pre
-
clinical and
clinical supplies:
Dr. Moreira provided
consulting services to a small biotech company
concerning the facilities requirements for
manufacturing pre
-
clinical and clinical supplies
of an investigational drug product under FDA
compliance. Advice was also provided on
process development and product
characterization issues (private client, 2007).




Biotechnology &
Pharmaceutical


Consultant Experience

11


Manufacturing Process Changes Approval
:
Dr. Moreira provided consulting services for a
pharmaceutical company in assessing process
changes in terms of US FDA CGMP approval
status and requirements as they impact the
final product (private client, 2006
-
2007).



International CGMPs Training Course:
Dr.
Moreira lectured a course to enhance
knowledge and needed skills to meet
international requirements for compliance with
the CGMP regulations and standards. This was
an in
-
house training program on International
CGMPs pertaining to the United States, Europe,
Latin America and Japan (private client, 2006).


Biotechnology &
Pharmaceutical


Consultant Experience

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Business & Technology



Peritus Consultants, Inc.

also provides the
following business consulting assistance:



High technology product market assessments
and market entry strategy development;


International partnering opportunities for market
expansion, R&D needs, and technology
acquisitions;


Technology and manufacturing feasibility studies;


Business Incubator development and
implementation strategies.



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Business & Technology


Consultant Experience


Technical Innovation Center (TIC) in
Washington County



Dr. Moreira conducted a
market and technical feasibility study for the
Washington County incubator. The study
assessed whether TIC should finance renovating
existing wet lab facilities or expanding facilities
by building an additional 3500 sq. ft. of wet lab
space.



Small
-
Scale GMP Manufacturing Facility
Study


Dr. Moreira assessed the market
opportunity for establishing a small
-
scale CGMP
biopharmaceutical manufacturing facility in the
northern U.S. (Pharmaceutical Manufacturer)


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Assessment of India's
National Cold Chain
System:
Dr. Moreira led a
team of consultants
assessing India's cold chain
system, diagnosing the main
factors limiting the
importation of perishable
goods. Recommendations
made for improving the agri
-
food industry’s
understanding of the cold
chain and the cold chain
infrastructure (USTDA,
2006).



Business & Technology


Consultant Experience

15

Education & Training


Peritus Consultants, Inc.

has a team of well
-
known and
experienced experts, with solid industry backgrounds, to
deliver its training programs.



Our company specializes in training courses customized to
the client's needs and offers both general facilitation services
and in
-
house training programs.



General facilitation services provide the client with the
opportunity to work directly with experts in the field of education
to design employee training programs tailored to the client's
needs.




Peritus Consultants, Inc
. provides the client with a trained
facilitator to execute employee training programs such that each
session is dynamic, interactive, informative, and as effective as
possible.



Our experts are available to provide in
-
house training to
companies in a variety of industries.



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Biotech/Pharma

In
-
House Training Program


The biotech/pharma in
-
house training
program provides the client with the
opportunity to utilize the expertise of the
consultants at
Peritus Consultants, Inc.

to customize training courses tailored to
the client's specific circumstances and
requirements.



Sample in
-
house training courses include:


Current Good Manufacturing Practices


Good Laboratory Practices


Biomanufacturing Technologies


Biosafety


Cell Culture and Fermentation Bioprocessing

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Example In
-
House

Training Programs


Shire Pharmaceuticals



International CGMPs


Camstar Systems



Overview of
Biomanufacturing


Quality Solutions

GMP training


Quimbiotec

Biomanufacturing training


Adimmune

GMP training


Lonza/Cambrex

Validation training


Invitrogen/Bioreliance

Biopharmaceutical
Processing Training


Charles River Labs

GMP training


McKesson Bioservices

GMP training


Abbott Labs

CMC Biologics training


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Organizatons our team has

consulted for include...


Paragon
Bioservices


BD Medical


Pharmaceutical
Systems


Lonza


Novartis


Human Genome
Sciences


Atral Cipan


GE Healthcare


Roche
Pharmaceuticals


Shire
Pharmaceuticals

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Contact Information

HEADQUARTERS


Peritus Consultants, Inc.


7610 Vulpe Court

Odenton, MD 21113 | USA

Telephone
: +1 443 254
-
3696

E
-
mail
:
info@peritusconsultants.com


www.peritusconsultants.com