Our Services
Using RegSource Consulting’s breadth of expertise, we provide Product Development and Regulatory Consulting to Pharmaceutical, Biotechnology, Generics and Medical Device companies
We have worked with the world’s leading companies to enhance their long-term competitive advantage. In doing so, we provide them with the appropriate resources and infrastructure and guide them through their key product development and regulatory decision milestones.
Our Services
Using RegSource Consulting’s breadth of expertise, we provide Product Development and Regulatory Consulting to Pharmaceutical, Biotechnology, Generics and Medical Device companies
We have worked with the world’s leading companies to enhance their long-term competitive advantage. In doing so, we provide them with the appropriate resources and infrastructure and guide them through their key product development and regulatory decision milestones.
Our Services
Our Services
Using RegSource Consulting’s breadth of expertise, we provide Product Development and Regulatory Consulting to Pharmaceutical, Biotechnology, Generics and Medical Device companies.
We have worked with the world’s leading companies to enhance their long-term competitive advantage. In doing so, we provide them with the appropriate resources and infrastructure and guide them through their key product development and regulatory decision milestones.
Our Consultants have helped clients lead transformational change and create new organizational models to meet new Regulatory policies or guidelines, and changes in product development strategy.
Below we have listed many of our services and we look forward to hearing how we can help you with your consulting needs.
Our Consultants have helped clients lead transformational change and create new organizational models to meet new Regulatory policies or guidelines, and changes in product development strategy.
Below we have listed many of our services and we look forward to hearing how we can help you with your consulting needs.
Regulatory Strategy
SPACE FILLER
Providing Regulatory Strategy is key to an organization’s success in either developing new products or maintaining compliance with current products. Our senior consultants have many years of experience in working with companies and worldwide regulatory agencies to ensure the most successful strategies are effectively executed.
We can provide strategic guidance in the following areas:
Regulatory Strategy
SPACE FILLER
Providing Regulatory Strategy is key to an organization’s success in either developing new products or maintaining compliance with current products. Our senior consultants have many years of experience in working with companies and worldwide regulatory agencies to ensure the most successful strategies are effectively executed. We can provide strategic guidance in the following areas:
Regulatory Operations
RegSource Consulting can provide Regulatory Operations planning to ensure successful submissions to all worldwide regulatory agencies.
Our consulting support includes:
Submissions Planning
Submissions Management
Selecting Regulatory and enterprise systems that meets the client’s needs to fulfill all Regulatory Affairs/Clinical/Nonclinical and CMC compliance and submission requirements from:
Regulatory Operations
RegSource Consulting can provide Regulatory Operations planning to ensure successful submissions to all worldwide regulatory agencies.
Our consulting support includes:
Submissions Planning
Submissions Management
Selecting Regulatory and enterprise systems that meets the client’s needs to fulfill all Regulatory Affairs/Clinical/Nonclinical and CMC compliance and submission requirements from:
Clinical
Our Clinical services provide clinical consulting to ensure successful clinical compliance and submissions to all worldwide regulatory agencies.
Our consulting support includes:
Submissions Management
Clinical
Our Clinical services provide clinical consulting to ensure successful clinical compliance and submissions to all worldwide regulatory agencies. Our consulting support includes:
Submissions Management
Nonclinical
Our Nonclinical support provides Nonclinical consulting to ensure successful Nonclinical compliance and submissions to all worldwide regulatory agencies.
Our consulting support includes:
Nonclinical
Our Nonclinical support provides Nonclinical consulting to ensure successful Nonclinical compliance and submissions to all worldwide regulatory agencies.
Our consulting support includes:
Chemistry, Manufacturing & Controls (CMC)
We provide CMC and Manufacturing support consulting to ensure successful compliance and submissions to all worldwide regulatory agencies.
Our consulting support includes:
Chemistry, Manufacturing & Controls (CMC)
We provide CMC and Manufacturing support consulting to ensure successful compliance and submissions to all worldwide regulatory agencies.
Our consulting support includes:
Compliance
Our Compliance support provides consulting to ensure successful compliance with current regulatory agency requirements.
Our consulting support includes:
Compliance
Our Compliance support provides consulting to ensure successful compliance with current regulatory agency requirements.
Our consulting support includes:
Project & Program Management
Our Project/Program Management support provides consulting to ensure successful Product Development and Regulatory Project Planning is provided, to achieve compliant and timely filings with national and international regulatory Agencies.
Our consulting support includes:
Project & Program Management
Our Project/Program Management support provides consulting to ensure successful Product Development and Regulatory Project Planning is provided, to achieve compliant and timely filings with national and international regulatory Agencies.
Our consulting support includes:
We provide regulatory and product development support to ensure all processes have been sufficiently designed within the Clinical/Nonclinical, Manufacturing and Commercial functions of an organization.
From ensuring high quality documents are submitted into regulatory dossiers for first time filings of major submissions, to post marketing activities for approved products, RegSource Consulting can help.
We provide regulatory and product development support to ensure all processes have been sufficiently designed within the Clinical/Nonclinical, Manufacturing and Commercial functions of an organization.
From ensuring high quality documents are submitted into regulatory dossiers for first time filings of major submissions, to post marketing activities for approved products, RegSource Consulting can help.