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Company Profile
RegSource Consulting is a leading consulting firm that integrates a broad range of capabilities, from Strategic Management consulting to Operational consulting. RegSource Consulting helps commercial, private, and government clients solve their toughest challenges by providing consulting in Strategy, Operations, Organizational, and Change Management in a broad arena, including Regulatory Affairs/Operations and enterprise Program/Project Management.
What We Do

Regulatory Affairs and Regulatory Operations
Designing strategic and operational implementation of regulatory plans, from organizational design to global submissions and implementation of regulatory strategy from Phase I - IV.
Implementation of all regulatory affairs and enterprise submissions processes and systems from eCTD to CTD training, template creation and creating global organizations to support worldwide submissions to regulatory agencies. Read More

Program & Project Management
We offer expertise in program and project management. Our focus includes all aspects of program and project management from mentoring, to inline execution, to project assessment and recovery. We place emphasis on understanding the people and processes to ensure the end solution meets each client’s goals. We have extensive experience in all phases of the project cycle, including feasibility assessment, technology selection, requirements gathering, solution implementation, testing, and overall installation management. Read More
Organizational and Change Leadership, IT Transformation and Implementation. Read More Read More
Where We Deliver

 

We Deliver by achieving maximum results with greatest efficiency, with primary focus on our clients requirements. We create solutions that can sustain long term stabilty and are scalable. We always assess and leverage the internal culture of each organization.  We build long term relationships with our clients and always ensure to deliver a solution right first time. Working collaboratively and with integrity and honesty, we come to better answers in teams than as individuals, where all opinions and options are considered, researched and considered prior to making any recommendations.

Why Choose RegSource Consulting?

 

RegSource Consulting offers a broad range of services that we customize to meet the goals of our clients.  We have industry professionals with extensive experience in practical aspects of implementing policies and procedures that meet regulatory requirements while supporting the client’s business interests and requirements.

Our approach is to create sustainable systems and processes that serve company's regulatory, compliance, IT, and business needs.  We provide very strong program and project management services to assure our client's key objectives for each projects are achieved.

We focus on optimizing all parts of the Drug Development process from Phase I to Phase IV, achieving efficiency in utilizing system and human/financial resources in achieving product approvals.  Read More