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.

Get Started with RegSource Consulting

Looking for help? Get in touch with us

Contact us

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.

Get Started with RegSource Consulting

Looking for help or to get involved with our team?

Get in touch with us today

Contact us