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WE GUIDE

From a “lead” compound to the initiation of first-in-human testing, the development of advanced therapeutic medicines is a lengthy, complex, uncertain and costly process.

The challenges are numerous including the characterisation of biological mechanisms, the translational to animal models, preclinical toxicology and pharmakocinetics, production and product characterization, bioanalytical testing, regulation and initiation of the first clinical trial.

It requires the coordination and effective interactions with different actors involved at various stages of this process such as academic and industrial partners, CROs and CDMOs and regulatory authorities.

ZEDGENE guides you to address those drug development challenges in order to diminish uncertainty and comply with budgets and timelines

Drug Dev

 

Drug development

Project management

Advanced therapies are at the cutting edge of new treatments.

The intrinsic complexity of developing advanced therapies requires a thorough understanding of these products as well knowing how to set up an effective organization.

 

Project management

The scientific, technological, regulatory, organization, financial and time aspects/constraints must be effectively managed throughout the project.

Based on our experience we bring our expertise in the global management of these types of project in a way that will optimize time efficiency, cost control and risk mitigation in line with corporate objectives. Our contributions include:

Advanced therapies are at the cutting edge of new treatments.

The intrinsic complexity of developing advanced therapies requires a thorough understanding of these products as well knowing how to set up an effective organization.

Participate in defining key milestones and deliverables

Identify critical path issues, define timelines and cost estimates

Manage project objectives and timelines

Collaborate with both internal and external partners to implement required studies

Facilitate core team activities, reporting, communication, creating project documentation

Host project meetings, generating meeting agendas and notes

Make recommendations to resolve misalignments, and mediate non-alignment between multiple units 

Report project status on a regular basis

Setting up and launching a biotechnology company can be very complex. Among many factors to consider, developing a comprehensive strategic marketing plan is crucial.

Strategic marketing

Strategic MKG

It’s allow to prepare the future of the company, and facilitates a common understanding among all stakeholders in the organization and for the external actors interacting with the company.

The strategic marketing plan is a key component of the global business plan.

With an adapted approach, we guide you to define and describe the main components of your strategic marketing plan :

Framework of the company

Company positioning and its environment

Competitive landscape

Key success factors

Strategic business areas

Opportunity Analysis

Organizational goals and strategies

Marketing opportunities and plan

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