Presentation on theme: "1 COMPANY OVERVIEW. 2 Company Overview Peritus Consultants is a minority/women-owned and operated business that provides specialized consulting and training."— Presentation transcript:
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:
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.
4 Office Locations Peritus Consultants, Inc. is headquartered in Maryland. Peritus Consultants, Inc. office
5 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.
6 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
9 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, ). 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
12 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.
13 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)
14 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.
16 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
17 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
18 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
19 Contact Information HEADQUARTERS Peritus Consultants, Inc Vulpe Court Odenton, MD | USA Telephone: