Leads to Development
Leads To Development (L2D) is a privately owned organization founded in 2009, based in Paris, France. It specializes in supporting clients through nonclinical development and clinical trial oversight solutions to enable rapid and successful entry of innovative products into clinical development. The company offers high-quality, proactive operational and regulatory support across all stages of drug development, spanning from discovery to market application, with expertise in various therapeutic areas and product types. L2D emphasizes social responsibility, sustainability, and inclusivity, actively promoting science careers, supporting charity initiatives, and maintaining a sustainable business model. Their team of international experts collaborates closely with clients to increase the chances of successful drug development while reducing time to milestones.
Industries
Nr. of Employees
small (1-50)
Leads to Development
Paris, Ile-de-France, France, Europe
Products
Nonclinical, CMC & Regulatory Drug Development Consulting Services
Leads to Development (L2D) provides expert consulting services in nonclinical, CMC, and regulatory drug development to accelerate new drug development with a committed team and extensive experience.
Nonclinical, CMC & Regulatory Drug Development Consulting Services
Leads to Development (L2D) provides expert consulting services in nonclinical, CMC, and regulatory drug development to accelerate new drug development with a committed team and extensive experience.
Services
Consultancy to define target product profiles, regulatory-aligned development plans, timelines, budgets and risk assessments across nonclinical and CMC domains.
Provision of project teams to coordinate CROs/CDMOs, monitor deliverables, manage timelines, and report to company management or boards.
Support for regulatory interactions and preparation of submission packages for EMA and FDA including briefing books, IND/IMPD/CTD sections and orphan designation requests.
Onsite and remote audits against GxP and ISO standards, audit reporting, corrective action planning, and IQAS design and auditing.
Sponsor oversight planning, GCP compliance monitoring, coordination of clinical vendors, and regular risk and progress reporting.
Consultancy to define target product profiles, regulatory-aligned development plans, timelines, budgets and risk assessments across nonclinical and CMC domains.
Provision of project teams to coordinate CROs/CDMOs, monitor deliverables, manage timelines, and report to company management or boards.
Support for regulatory interactions and preparation of submission packages for EMA and FDA including briefing books, IND/IMPD/CTD sections and orphan designation requests.
Onsite and remote audits against GxP and ISO standards, audit reporting, corrective action planning, and IQAS design and auditing.
Sponsor oversight planning, GCP compliance monitoring, coordination of clinical vendors, and regular risk and progress reporting.
Expertise Areas
- Nonclinical development
- CMC strategy and planning
- Regulatory compliance for EMA and FDA
- Quality assurance and GxP auditing
Key Technologies
- Nonclinical study design
- CMC strategy and documentation
- Pharmacology and toxicology assessment
- Pharmacokinetics evaluation
News & Updates
Upcoming events in Europe and USA
Leads To Development attends various in-person and virtual events across Europe and the USA, providing opportunities for networking and collaboration.
Leads To Development's Expertise in Drug Development
An overview of the company's extensive experience managing over 160 nonclinical development programs and their success in obtaining clinical trial authorizations.
Client Testimonials Highlighting Success
Clients praise L2D for operational support, regulatory expertise, and contribution to clinical milestones and approvals.
160+ Programmes Delivered
Leads To Development has managed over 160 nonclinical development programmes.
100% Clinical Trial Authorization Success Rate
The company has a perfect track record in obtaining clinical trial authorizations.
Projects Out-licensed for Over $900M
Several projects managed by L2D have been successfully out-licensed at various development stages, including a recent deal exceeding $900 million.
Upcoming events in Europe and USA
Leads To Development attends various in-person and virtual events across Europe and the USA, providing opportunities for networking and collaboration.
Leads To Development's Expertise in Drug Development
An overview of the company's extensive experience managing over 160 nonclinical development programs and their success in obtaining clinical trial authorizations.
Client Testimonials Highlighting Success
Clients praise L2D for operational support, regulatory expertise, and contribution to clinical milestones and approvals.
160+ Programmes Delivered
Leads To Development has managed over 160 nonclinical development programmes.
100% Clinical Trial Authorization Success Rate
The company has a perfect track record in obtaining clinical trial authorizations.
Projects Out-licensed for Over $900M
Several projects managed by L2D have been successfully out-licensed at various development stages, including a recent deal exceeding $900 million.