Clementi Associates
Consulting firm focused on medical and regulatory affairs for drug and combination product development. Provides regulatory strategy, FDA engagement and submissions, lifecycle management for INDs and DMFs, electronic submission workflows, clinical development planning, and program-specific regulatory support using secure document and project management systems.
Industries
Nr. of Employees
small (1-50)
Clementi Associates
919 Conestoga Rd, Building 3, Suite 312, Bryn Mawr, PA 19010, USA
Products
IND Management and FDA Engagement
Management of Investigational New Drug (IND) applications and interactions with the FDA throughout the drug development lifecycle.
Regulatory Affairs Consulting
Consulting on regulatory strategy, submissions, and compliance for pharmaceutical product development.
Clinical Development Planning
Strategic planning and advisory services for clinical trial design and development programs.
Document Preparation and Electronic Submission Support
Preparation and management of regulatory documents and electronic submissions to regulatory agencies.
IND Management and FDA Engagement
Management of Investigational New Drug (IND) applications and interactions with the FDA throughout the drug development lifecycle.
Regulatory Affairs Consulting
Consulting on regulatory strategy, submissions, and compliance for pharmaceutical product development.
Clinical Development Planning
Strategic planning and advisory services for clinical trial design and development programs.
Document Preparation and Electronic Submission Support
Preparation and management of regulatory documents and electronic submissions to regulatory agencies.
Services
Regulatory planning, FDA engagement, meeting preparation and strategic regulatory advice.
Preparation, electronic publishing and lifecycle maintenance of INDs, DMFs and related regulatory submissions.
Set up and execute cloud-based document databases, naming conventions, template guidance, eCTD publishing/validation and gateway submission.
Conduct cGMP audits at sponsor or CMO sites and provide manufacturing-related regulatory guidance.
Regulatory risk assessment and regulatory success probability analysis to support M&A, licensing and investment decisions.
Advisory and submission support tailored to university and investigator-sponsored IND programs.
Regulatory planning, FDA engagement, meeting preparation and strategic regulatory advice.
Preparation, electronic publishing and lifecycle maintenance of INDs, DMFs and related regulatory submissions.
Set up and execute cloud-based document databases, naming conventions, template guidance, eCTD publishing/validation and gateway submission.
Conduct cGMP audits at sponsor or CMO sites and provide manufacturing-related regulatory guidance.
Regulatory risk assessment and regulatory success probability analysis to support M&A, licensing and investment decisions.
Advisory and submission support tailored to university and investigator-sponsored IND programs.
Expertise Areas
- Regulatory compliance and FDA engagement
- IND and DMF preparation and lifecycle management
- Electronic submissions and eCTD workflows
- Clinical development planning and Phase I study design
Key Technologies
- XML eCTD publishing and validation
- Electronic submission gateways
- Secure cloud file exchange and off-site backup
- Document management systems
News & Updates
Blog post covering considerations for new drug testing and development planning.
Blog post discussing potential impacts of nanotechnology on medicine.
Reported filing of over 100 submissions to CDER, CBER and CVM within a 12-month period.
Blog post covering considerations for new drug testing and development planning.
Blog post discussing potential impacts of nanotechnology on medicine.
Reported filing of over 100 submissions to CDER, CBER and CVM within a 12-month period.