Services
Technical Development and Regulatory Strategy
With our combined experience of supporting more than 100 biologics in different stages of development from discovery to commercialization, we are in a unique position to guide your biologics technical development and regulatory strategy to a successful outcome. We support full biologics CMC package development including the writing of the regulatory submission package and questions and answers to health authorities. Our current understanding of different regulatory requirements worldwide and work experience worldwide with CROs and CDMOs, allows us to navigate complex development programs from start to health authority approval quickly and economically as possible. We actively participate in scientific and regulatory conferences to gain the knowledge of changing requests and trends of health authority expectations to support our clients’ successful health authority submissions.
Business Strategy and Operations
Experience gained from working with small start-up to large biotech companies allow us to integrate tailored development and business strategies for your organizational requirements and goals. With the approval of defined business and development strategies, we collaborate with clients to operationalize strategies internally and to continuously improve accomplishments for the long-term success of the company.
Interim Management
Our team members have extensive experience in the pharma/biotech industry. We are eager to support your company as an interim executive/management to support your company's journey. We have supported companies from start-up to IPOs, as interim functional area management consultants from discovery to late phase development.
Biotech Start-up
Successful and long-term working relationships with start-ups, allow us to share our knowledge with start-up entrepreneurs from ideation to successful clinical stage company. We have provided start-up capital as founders or as angel investor for companies developed with our collaborations. To grow and enhance the value of the start-ups, we work with the start-up leadership to raise funding and business development activities.
Biotech Placement
Unique understanding and extensive work experience in the biotechnology, cell and gene therapy industry position us to provide our clients with a diverse talent pool to select their team members. Our extensive industry network could guarantee the best candidate for your company's success.