At Q2CR, we offer comprehensive regulatory consultation and training services designed to help you navigate the complex regulatory landscape, ensure compliance, and enhance the skills and knowledge of your team. Our expert guidance covers all phases of clinical research and development, ensuring your projects meet regulatory requirements and industry best practices.
A. Regulatory Consultation Services
Strategic Regulatory Planning
Regulatory Pathway Analysis
Assessing and defining optimal regulatory pathways for product development and approval.
Regulatory Strategy Development
Crafting detailed regulatory strategies tailored to your product and target markets.
Regulatory Risk Assessment
Identifying potential regulatory risks and developing mitigation strategies.
Regulatory Submissions
IND/CTA Preparation
Preparing Investigational New Drug (IND) applications and Clinical Trial Applications (CTA) for submission to regulatory authorities.
NDA/BLA Submissions
Assisting with the preparation and submission of New Drug Applications (NDA) and Biologics License Applications (BLA).
ANDA Submissions
Providing support for Abbreviated New Drug Applications (ANDA) for generic products.
510(k) and PMA Submissions
Assisting with the preparation and submission of 510(k) notifications and Premarket Approval (PMA) applications for medical devices.
Regulatory Compliance
GCP, GLP, and GMP Compliance
Ensuring compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) standards.
Audit Preparation and Support
Preparing for regulatory inspections and audits, including mock audits and audit readiness assessments.
Regulatory Affairs Outsourcing
Providing outsourced regulatory affairs support for ongoing compliance and submissions management.
Regulatory Intelligence
Regulatory Updates
Keeping you informed of the latest regulatory changes and trends affecting your products.
Competitive Intelligence
Analyzing competitor regulatory strategies and outcomes to inform your approach.
Market Entry Requirements
Assessing regulatory requirements for entering new markets.
Labelling and Advertising Compliance
Labelling Development
Developing compliant product labeling, including package inserts, user manuals, and labelling for global markets.
Advertising and Promotion Review
Reviewing promotional materials to ensure compliance with regulatory requirements and guidelines.
B. Regulatory Training Services
Customized Training Programs
Regulatory Fundamentals
Providing foundational training on regulatory requirements and processes for clinical trials, drug development, and medical device approvals.
Advanced Regulatory Training
Offering advanced courses on specific regulatory topics, such as IND/NDA/BLA submissions, post-market surveillance, and regulatory strategy.
Regulatory Updates and Trends
Educating your team on the latest regulatory updates, trends, and best practices.
Good Practice Training
GCP Training
Training on Good Clinical Practice (GCP) guidelines to ensure the ethical and scientific quality of clinical trials.
GLP Training
Training on Good Laboratory Practice (GLP) standards to ensure the quality and integrity of non-clinical laboratory studies.
GMP Training
Training on Good Manufacturing Practice (GMP) standards to ensure the quality and safety of manufactured products.
Specialized Regulatory Topics
Regulatory Submission Training
In-depth training on preparing regulatory submissions, including eCTD (electronic Common Technical Document) format.
Audit and Inspection Readiness
Training on preparing for regulatory audits and inspections, including mock audits and response strategies.
Quality Management Systems (QMS)
Training on implementing and maintaining effective Quality Management Systems in compliance with regulatory standards.