We build your product-specific global development strategy from early stage development to product launch. We provide guidance on your overall development strategy including all regulatory, CMC, clinical and non-clinical aspects.

• Preparation of integrated development strategy and definition of key development milestones for CMC, non-clinical, clinical, regulatory (Europe, USA)

• Target product profile (TPP) definition

• Comprehensive time and budget planning for complete development program

• Assessment of options to accelerate product development

• Planning of development project scenarios for decision-making

• Preparation of agency meetings and management presentations

• Competitive landscape analysis and regulatory intelligence

We provide cross-functional team leadership and project management to efficiently execute and accelerate your product development projects. We use proven, best practice project management and steering tools that guide your project all the way from start till closure.

• Management of development programs, complex projects, and multi-project portfolios including project planning and tracking of timelines, quality, costs

• Planning and execution of tech transfer projects

• Implementation of project management processes and tools

• CMO and vendor management

• Project reporting and performance measurement

• Crisis and change management

• Management of grants and public funding

We apply the following project management standards and best practices:

• PMI Project Management Body of Knowledge

• PMI Agile Practice Guide

• ISPE Good Practice Guide Project Management for the Pharmaceutical Industry

• ISPE Good Practice Guide Technology Transfer

We support you with regulatory and medical writing of your submissions to authorities. We provide you with flexible and fast hands-on support for your day-to-day operations to get things done, in time and where you need it.

• Preparation and management of scientific advice meetings and regulatory interactions including meeting request and briefing documentation, organization and management of procedure (EMA, FDA, national competent authorities, Health Canada)

• Writing support for investigational medicinal product dossier (IMPD), investigational new drug (IND) applications, marketing authorisation application (MAA), new drug application (NDA), biologics license application (BLA)

• Preparation of requests for regulatory expedited programs such as PRIME, breakthrough, RMAT designation

• Preparation of applications for orphan drug designation (ODD) and humanitarian use device (HUD) designation

• GMO documentation for clinical trial applications, environmental risk assessment (ERA)

• Writing and preparation of applications for grants and public funding

• EU representative and primary contact in all dealings with EMA

• Preparation and management of SME applications to EMA

We facilitate the translation of early stage research data and product ideas into strategies for successful technology transfer and product development. Together with you, we define the critical elements of your product development strategy and how to implement it.

• Preparation of project plan and development scenarios to guide decision-making

• Planning and execution of tech transfer projects

• Mapping of regulatory requirements to initiate first-in-human clinical studies

• Training on specific development topics of interest