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:
Strategy for Agency Meetings
GLP/GCP/GMP Implementation Strategies
Developing Target Product Profiles
Developing Clinical Development Plans
Nonclinical Development Strategies
Chemistry & Manufacturing Strategies
Lifecycle Management Planning
Developing regulatory pathways for accelerated approvals
Developing cost effective and efficient development strategies
Responses to Agency Questions
Electronic Submission Strategies
Labelling Strategy
Scientific Advice
Global Regulatory Submission Strategies
Pharmacovigilance Strategies
Ensuring compliance and effective Quality Systems
Effective Program Management to accelerate product approval timelines
Response to Regulatory Agency deficiency letters
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:
Strategy for Agency Meetings
GLP/GCP/GMP Implementation Strategies
Developing Target Product Profiles
Developing Clinical Development Plans
Nonclinical Development Strategies
Chemistry & Manufacturing Strategies
Lifecycle Management Planning
Developing regulatory pathways for accelerated approvals
Developing cost effective and efficient development strategies
Responses to Agency Questions
Electronic Submission Strategies
Labelling Strategy
Scientific Advice
Global Regulatory Submission Strategies
Pharmacovigilance Strategies
Ensuring compliance and effective Quality Systems
Effective Program Management to accelerate product approval timelines
Response to Regulatory Agency deficiency letters
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
Regulatory Publishing and planning for all major regulatory submissions
Publishing plans for all type of submission types
MAA/NDA/BLA to CTD section mapping
eCTD format conversion planning
Assisting organizations create/publish and ship CTD and eCTD type applications to worldwide agencies
General consulting on electronic publishing in the global regulatory environment
Submission Project Management for national and international Agencies
Clinical/Nonclinical/CMC functional group regulatory submission planning
Detailed Submission Metrics
Regulatory Guidance/Standards Interpretation for regulatory submissions (how and when to apply)
Electronic and Paper submission planning
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:
Collecting user requirements
Process Mapping (As is/To be)
Writing URS/FRS documents
System selection
Business validation support
System implementation
Template design & creation
Implementation of Document Management Systems
Writing training manuals/SOP’s
Education Workshops
Creating & implementing communication plans
Project and Program Management
Enterprise implementation support
Retention Policies
Legacy Data Migration Planning
Structured Product Labeling Submissions
Regulatory Operations
RegSource Consulting can provide Regulatory Operations planning to ensure successful submissions to all worldwide regulatory agencies.
Our consulting support includes:
Submissions Planning
Regulatory Publishing and planning for all major regulatory submissions
Publishing plans for all type of submission types
MAA/NDA/BLA to CTD section mapping
eCTD format conversion planning
Assisting organizations create/publish and ship CTD and eCTD type applications to worldwide agencies
General consulting on electronic publishing in the global regulatory environment
Submissions Management
Submission Project Management for national and international Agencies
Clinical/Nonclinical/CMC functional group regulatory submission planning
Detailed Submission Metrics
Regulatory Guidance/Standards Interpretation for regulatory submissions (how and when to apply)
Electronic and Paper submission planning
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:
Collecting user requirements
Process Mapping (As is/To be)
Writing URS/FRS documents
System selection
Business validation support
System implementation
Template design & creation
Implementation of Document Management Systems
Writing training manuals/SOP’s
Education Workshops
Creating & implementing communication plans
Project and Program Management
Enterprise implementation support
Retention Policies
Legacy Data Migration Planning
Structured Product Labeling Submissions
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
Development of Clinical Development Plans
Clinical Trial Design and Trial implementation Planning
Review of Clinical Sections of submissions
Assist in a creation or reorganization of a Clinical Operation Department
Creation of Clinical SOP’s
Provide ongoing regulatory oversight of clinical trials
Assist in writing Investigator Brochures/Protocols
Clinical Trial Application Preparation
Provide support in submission of regulatory documentation required for national and international Ethic Committees/IRB and IBC’s
Provide support for a RAC advisory committee meeting
Provide support in creation of clinical documentations for regulatory submission
Provide support in Development and submission of a RAC submission to the NIH
Ensure GCP compliance through GCP Audits and regulatory gap assessment.
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
Development of Clinical Development Plans
Clinical Trial Design and Trial implementation Planning
Review of Clinical Sections of submissions
Assist in a creation or reorganization of a Clinical Operation Department
Creation of Clinical SOP’s
Provide ongoing regulatory oversight of clinical trials
Assist in writing Investigator Brochures/Protocols
Clinical Trial Application Preparation
Provide support in submission of regulatory documentation required for national and international Ethic Committees/IRB and IBC’s
Provide support for a RAC advisory committee meeting
Provide support in creation of clinical documentations for regulatory submission
Provide support in Development and submission of a RAC submission to the NIH
Ensure GCP compliance through GCP Audits and regulatory gap assessment.
Nonclinical
Our Nonclinical support provides Nonclinical consulting to ensure successful Nonclinical compliance and submissions to all worldwide regulatory agencies.
Our consulting support includes:
Preparation of Pharmacology and Toxicology sections for regulatory submissions
Pharmacology and Toxicology program review and development
Gap Assessment of current Nonclinical programs
Identification of Nonclinical testing laboratories
GLP inspections
Provide support in development and submission of nonclinical regulatory documentation required for national and international dossiers
Nonclinical
Our Nonclinical support provides Nonclinical consulting to ensure successful Nonclinical compliance and submissions to all worldwide regulatory agencies.
Our consulting support includes:
Preparation of Pharmacology and Toxicology sections for regulatory submissions
Pharmacology and Toxicology program review and development
Gap Assessment of current Nonclinical programs
Identification of Nonclinical testing laboratories
GLP inspections
Provide support in development and submission of nonclinical regulatory documentation required for national and international dossiers
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:
Gap Analysis of all current CMC processes
Preparation and review of all CMC sections for regulatory submission
Assistance in validation activities related to: Facilities, Manufacturing Processes, Analytical Assays, Equipment, Computer Systems Validation, & Validation master plans
Assistance with the creation of Comparability Protocols
Assistance with Technology Transfers
Oversight of Contract Manufacturing Organizations
Oversight of Contract Testing Laboratories
GMP Audits
Creation of GMP SOP’s
Creation of Quality Manuals
Creation of QA/QC SOP’s
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:
Gap Analysis of all current CMC processes
Preparation and review of all CMC sections for regulatory submission
Assistance in validation activities related to: Facilities, Manufacturing Processes, Analytical Assays, Equipment, Computer Systems Validation, & Validation master plans
Assistance with the creation of Comparability Protocols
Assistance with Technology Transfers
Oversight of Contract Manufacturing Organizations
Oversight of Contract Testing Laboratories
GMP Audits
Creation of GMP SOP’s
Creation of Quality Manuals
Creation of QA/QC SOP’s
Compliance
Our Compliance support provides consulting to ensure successful compliance with current regulatory agency requirements.
Our consulting support includes:
Gap Analysis of Compliance deficiencies within: Clinical, Nonclinical, Manufacturing, Quality Assurance and Control
Quality Systems Assessment
Advertising and Promotional Compliance
Labeling and Packaging Compliance
Regulatory Agency Inspection Preparation: Creation of SOP & Processes, Staff Training, Mock Inspections
Pre-Approval Inspection preparations
Facility compliance evaluations
GLP/GCP/GMP Audits
Regulatory Product/Project Management
Response to Regulatory Agency deficiency letters
CE Marketing Certification and Surveillance Inspection Reports
Confidential Corporate Compliance Assessments for Senior Management
Creation of Corporate Compliance Committees
Development of Corporate Compliance Reports for Senior Management
Due Diligence Preparations or External Assessments
Regulatory Agency Inspection Preparation
Creation of Quality Manuals
Compliance
Our Compliance support provides consulting to ensure successful compliance with current regulatory agency requirements.
Our consulting support includes:
Gap Analysis of Compliance deficiencies within: Clinical, Nonclinical, Manufacturing, Quality Assurance and Control
Quality Systems Assessment
Advertising and Promotional Compliance
Labeling and Packaging Compliance
Regulatory Agency Inspection Preparation: Creation of SOP & Processes, Staff Training, Mock Inspections
Pre-Approval Inspection preparations
Facility compliance evaluations
GLP/GCP/GMP Audits
Regulatory Product/Project Management
Response to Regulatory Agency deficiency letters
CE Marketing Certification and Surveillance Inspection Reports
Confidential Corporate Compliance Assessments for Senior Management
Creation of Corporate Compliance Committees
Development of Corporate Compliance Reports for Senior Management
Due Diligence Preparations or External Assessments
Regulatory Agency Inspection Preparation
Creation of Quality Manuals
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:
Development of Product Development Plans
Development of Target Product Profiles
Development of Clinical Development Plans
Nonclinical Development Strategies
Program Product Management
Product Project Management
Functional Group Program Management of Regulatory Deliverables
Submission Metrics
Organizational Design to Optimize Regulatory Submissions
Risk Management
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:
Development of Product Development Plans
Development of Target Product Profiles
Development of Clinical Development Plans
Nonclinical Development Strategies
Program Product Management
Product Project Management
Functional Group Program Management of Regulatory Deliverables
Submission Metrics
Organizational Design to Optimize Regulatory Submissions
Risk Management
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.