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S4BT’s Project Management Service is a highly specialized consulting service for end-to-end project management at all stages of a product’s life cycle: research and development, commercialization, divestment or delisting.
The S4BT consulting team consists of certified program managers and project managers (PMP®, Yellow Belt, ISIPM®, PRINCE2® Foundation, CAPM®, CSCP®) with specialized technical know-how and robust experience in executing projects alongside pharmaceutical companies and CDMOs.
S4BT’s Project Management Service is a highly specialized consulting service for end-to-end project management at all stages of a product’s life cycle: research and development, commercialization, divestment or delisting.
The S4BT consulting team consists of certified program managers and project managers (PMP®, Yellow Belt, ISIPM®, PRINCE2® Foundation, CAPM®, CSCP®) with specialized technical know-how and robust experience in executing projects alongside pharmaceutical companies and CDMOs.
Our activities include:
* For Technology Transfer, we offer consulting services either as a Project Manager or Technical Lead.
Our activities include:
* For Technology Transfer, we offer consulting services either as a Project Manager or Technical Lead.
We have been operating for about 30 years in the pharmaceutical and life science sectors.
Our consultants are progtam and senior project managers with robust experience managing projects in national and international settings for large companies in the industry.
We move with flexibility of time and place to meet customers' needs.
We routinely support international travel to reach plants.
We also have technology to work both remotely and from the customer's site without any difficulty.
With The PM Service, the client decides on the job profile and how long he or she will need it, resulting in: a reduction in fixed Personnel costs; flexible production capacity; and tailored specific skills.
S4BT consultants have excellent knowledge of cGXP, manufacturing processes, Technology Transfer, and change management.
We also invest in the continuous training of our consultants, who have highly specialized know-how in Pharma & Life Science and are always up-to-date with the current environment.
Relying on the expertise and know-how of S4BT Project Management Service consultants not only helps complete a Project but also provides advice for continuous improvement of flows and processes.
With the Project Management Service, client companies have a Business Unit Manager who follows the consultant's path and is a constant point of contact to meet the client's needs, ensuring a personalized customer experience and high performance.
We have been operating for about 30 years in the pharmaceutical and life science sectors.
Our consultants are progtam and senior project managers with robust experience managing projects in national and international settings for large companies in the industry.
We move with flexibility of time and place to meet customers' needs.
We routinely support international travel to reach plants.
We also have technology to work both remotely and from the customer's site without any difficulty.
With The PM Service, the client decides on the job profile and how long he or she will need it, resulting in: a reduction in fixed Personnel costs; flexible production capacity; tailored specific skills.
S4BT consultants have excellent knowledge of cGXP, manufacturing processes, Technology Transfer, and change management.
We also invest in the continuing education of our consultants, who have highly specialized know-how in Pharma & Life Science and are always up-to-date with the current environment.
Relying on the expertise and know-how of S4BT Project Management Service consultants not only helps complete a Project but also provides advice for continuous improvement of flows and processes.
With the Project Management Service, client companies have a Business Unit Manager who follows the consultant's path and is a constant point of contact to meet the client's needs, ensuring a personalized customer experience and high performance.
Client:
Multinational pharmaceutical company that has always been engaged in research, development and commercialization of innovative drugs with one of the most modern and state-of-the-art factories.
For the Group, the transfer of products from one country to another plays a strategic role that requires expert management of the task.
S4BT specialists make essential contributions in all Technology Transfer projects in which they are involved. I am extremely satisfied with the technical expertise and management skills demonstrated
We are a company of more than 80 specialists and have been a reliable partner of excellence for Pharma & Life Science companies for about 30 years, to whom we provide software solutions and specialized consulting.
S4BT Consulting has specialized know-how in the areas: Quality Assurance; Project Management; Technology Transfer; Process, Cleaning & Packaging Validation; NPI; Packaging Engineering; Equipment & Facilities Qualification; CSV & Data Integrity.
PRAGMA4U is the platform for digitizing processes in regulatory compliance.
eQMS, DMS, LMS, WFMS multiple technologies in one platform.
PRAGMA4U is flexible, adapts to the needs of companies of any size, and enables sustainable growth.
Designed with human centerd approach, it offers a path to process optimization.
Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.
The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.
PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.
During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes
It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.
The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.
PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.
Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes