Appleton Greene & Co Global – Executive Summary
Business Administration by Appleton Greene & Co Global – Montreal Toronto New York London Boston Biotechnology Healthcare Consultancy Pharmaceutical
Our analysis, undertaken during the last 5 years, has illustrated that many companies invest heavily in the acquisition of pre-packaged solutions, without needing or using the entire package. As economists say, there is money left on the table. Dr. Popa has created a solution by providing tailor made services for organizations that want to run their projects on time and on budget, while adhering to the highest quality standards. Business administration is the process of managing a business or non-profit organization, so that it remains stable and continues to grow. The administration of a business includes the performance or management of business operations and decision making, as well as the efficient organization of people and other resources, to direct activities toward common goals and objectives. In general, administration refers to the broader management function, including the associated finance, personnel and MIS services. In some analyses, management is viewed as a subset of administration, specifically associated with the technical and operational aspects of an organization, distinct from executive or strategic functions. Administrators, broadly speaking, engage in a common set of functions to meet the organization’s goals. – Appleton Greene & Co Global
Appleton Greene & Co Global – The regulatory process can look very complex, whether your company is a multinational pharmaceutical or medical device company, or a company that is newly emerging in the marketplace. With proper planning and groundwork, successful submissions do not require last minute scrambles and overtime. Due to our extensive experience we can help you to deliver electronic submissions on time, on budget, and with less stress. Our Regulatory Affairs department are fully trained and experienced in preparing all major regulatory submissions for Phase II-III clinical trials, including complex multinational submissions for pharmaceutical products, biological products and medical devices. We prepare a full range of drug regulatory submissions for product licensing in Canada, USA and Europe: Abbreviated new drug applications (ANDA); Biologics license applications (BLA); Clinical trial authorization/application (CTA); Clinical trial notifications (CTN); Common technical document (CTD); Drug master files (DMF); Investigational device exemptions (IDE); Investigational new drug applications (INDA); Marketing authorization applications (MAA); New drug applications (NDA); New drug submissions (NDS); Orphan drug applications (ODA); Pre-market approvals (PMA).
Appleton Greene & Co Global – The linking of new leadership with attempted cultural change is not surprising when you consider that leadership and culture are essentially two sides of the same coin. A new CEO (or an existing one) can delegate many tasks, but the task of setting the culture cannot be delegated. Why? Because there is compelling evidence that business performance and culture are closely linked. If the CEO wants the business to achieve its corporate objectives, then the culture has to be right. In a major research program, Harvard professors John Kotter and James Heskett found consistent correlation between robust, engaged cultures and high-performance business results. Organisational culture is a problem when the way in which the organisation usually operates puts obstacles in the way towards achievement. Some examples: the goals of the organisation demand an external orientation of the members, but the organisational culture is characterized by internal orientation; transparency is needed to be accountable and to function democratically, but the tradition to involve family members and to favor them, may makes transparency cloudy; being value driven as a main characteristic of a NGO stands not well with the business-like attitude of our professionals; productivity, being directed towards goals, may be hindered by the grown habit to intervene in each other’s work, directing most of the energy to each other instead of to the product; the not-outspoken rule not to intervene in each other’s work (the non-intervention principle) may hinder the ideal working method of sharing ideas, innovations, solutions and problems; because of the one-sided fixation on ideology, satisfaction of personal needs may be considered as forbidden; a grown emphasis on output may have led to the situation in which reflection (base for learning) is considered a waste of time; organisational culture is not the result of just a decision, but the outcome of a lasting process, in which the attitude, beliefs and behavior of people are gradually shaped. Organisational culture, even if not objectively effective, is always a logical adaptation to a changed environment. Organisational culture may be compared to coping mechanisms: once effective in one specific situation, but internalized, unconscious familiar, and hardly noticeable for the owner. We will give you the processes and will guide you through the complex processes of corporate change and will make it a success.
Appleton Greene & Co Global – The regulatory process can look very complex, whether your company is a multinational pharmaceutical or medical device company or whether a company that is newly emerging in the marketplace. With proper planning and groundwork, successful submissions do not require last minute scrambles and overtime. Due to our extensive experience we can help you deliver electronic submissions on time, on budget, and with less stress. Having documentation accessible and organized for regulatory research and inspections for the clinical trials and then for the whole life of the product is one of the most important regulatory aspects. We help you through our specific and Customizable Document Management System (C-DMS) to have all documents filed and accessible all the time. For the clinical research sector this also opens us the possibility to create an electronic submission so that FDA reviewers receive them the day they are published. In addition we conduct critical appraisal and gap analysis, a technique for determining what useful information is missing in a submission and suggesting solutions for solving the problem of our clients’ submissions. Electronic submission services are available in addition to traditional paper document services.
Appleton Greene & Co Global – For each project, we select and assign Project Managers with relevant experience that corresponds to client’s requirements and specifications. We, along with our clients, gather necessary trial-specific information, analyse the project goals, assess risks, plan, run the project simulation, identify any gaps and then execute the project. During the preparation process, client’s team is able to get to know our candidates for Project Management role and identify the most suitable person. Since we know that the key to a successful trial is project management, our Project Managers “own” their projects and are fully accountable for the outcomes. They are provided and use the state-of-the-art technology to be in real time communication with the sites, the client and the study team in order to maintain control over the project. Our Project Managers have to respond quickly to the client’s needs, to anticipate possible problems and to provide the best solution available. We provide the project management that the trial needs and the relationship to the client that is needed to succeed. The Global Project Manager will have the following responsibilities: Ensure the study complies with all regulatory guidelines; Participates in all stages of project development – planning, execution and close out; Orchestrates the project team performance to achieve required efficiency and cohesiveness; Serves as a key liaison between the project team, Client and external vendors; Keeps the client updated on the project developments; Offers a flexible proactive approach to resolve issues promptly and effectively; Provide weekly reports of the project including identification of potential risks and contingency plans; Ensures consistency in quality and procedures; Becomes part of the client’s decision process by offering proactive suggestions and solutions; Assesses emerging issues and resolves them according to the project-specific documents; escalates the issues to senior management and client as necessary; Ensures the project deadlines/ deliverables are met; Manages and owns the project; Manages the budget and provides financial managerial reports as necessary. Working with us provides many advantages: Our PM are equally or more experienced than those from larger companies and the turnover rate is lower; Our PMs allow clients to maintain control over decisions to a level of control where larger companies may take total control over the project; We provide more value and ROI due to lower operational costs; We focus on each project as if it would be our own as we want the project to succeed and the client to be fully satisfied. We want our clients to return to us; We provide a higher level of trial detail because we know that this detail is critical to the success of the project and this could be a life and death situation for smaller clients.
Appleton Greene & Co Global – Quality assurance and compliance is mandatory in order to ensure the integrity of the clinical trials. Our experienced GCQA department helps our clients to verify the integrity of the scientific data and adhere to the protocols and to the regulatory requirements. Our GCQA staff is knowledgeable about the local, national and international regulations and guidelines. Our GCQA team contains also physicians and legal experts with GCQA experience. We provide a full range of GCP Quality Assurance and Compliance services.
Dr. Popa MBA MD Dip Mgt is an Accredited Senior Consultant (ASC) at Appleton Greene
Appleton Greene & Co Global – Dr. Popa is an approved Senior Consultant at Appleton Greene and he has experience in management, globalization and marketing. He has achieved a Master in Business Administration, a Doctor in Medicine and a Professional Diploma in Management. He has industry experience within the following sectors: Biotechnology; Healthcare; Consultancy; Government and Oil & Gas. He has had commercial experience within the following countries: United States of America; Canada and United Kingdom, or more specifically within the following cities: New York NY; Boston MA; Montreal; Toronto and London. His personal achievements include: facilitated performance management improvement process; facilitated quality improvement process; facilitated regulatory compliance improvement; facilitated corporate change and learning and facilitated clinical research operations improvement. His service skills incorporate: project management; quality assurance; regulatory compliance; corporate change and medical affairs.
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20 Consulting Service Examples
There are currently some 650 Accredited Consulting Services (ACS) provided by Appleton Greene worldwide. Here are 20 examples.
01. Business Administration
02. Business Development
03. Business Optimization
04. Crisis Management
05. Customer Development
06. Energy Management
07. Entrepreneurial Leadership
08. Investment Consulting
09. Marketing Optimization
10. Marketing Transformation
11. Process Excellence
12. Product Management
13. Risk Analysis
14. Soulful Leadership
15. Sustainable Development
16. Transitional Growth
17. Value Innovation
18. Retirement Planning
19. Change Strategy
20. Product Lifecycle
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