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Biotech
Game-changing integrated solutions to help secure global product development
We understand your unique challenges. We listen to your needs and provide tailored, flexible and integrated solutions to optimize & accelerate your product development.
KEY FIGURES
80%
Of our clients are biotech companies
>90%
Of our consultants have a Ph.D / M.Sc. /Pharm. D.
100%
Scientifically trained subject matter experts
Health Authority Experience
We believe that each client is unique and requires a tailored approach. With a team of former regulatory agency and national competent authorities and decades of experience, we solve problems before they arise. We remove barriers so that you can focus on your breakthrough.
Deep Therapeutic Experience
We have a wealth of expertise in major therapeutic areas with particular strength in oncology, immunology, infectious disease, hematology, cardiology, ophthalmology, gastroenterology, respiratory disease, vaccines, bone metabolism, cell and gene therapy, rheumatology, neuroscience and CNS, from early phases through post-approval.
FAQs
What is SME status and how can it benefit emerging biotech companies in the regulatory process?
SME status, recognized by regulatory agencies such as the European Medicines Agency (EMA), offers several advantages for small and medium-sized biotech firms.
Benefits may include reduced fees for regulatory submissions, expedited review processes, and access to specific funding opportunities. Obtaining SME status can enhance a company’s credibility and facilitate smoother interactions with regulatory authorities, ultimately aiding in the development and commercialization of innovative therapies.
Learn more: Are you making the most of the incentives and benefits that are available to support small business?
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How can emerging biotech companies navigate the IND application process?
The Investigational New Drug (IND) application is a critical step for biotech companies seeking to initiate clinical trials in the US.
This process involves submitting comprehensive data on preclinical studies, proposed clinical trial protocols, and manufacturing information. Early and thorough preparation can improve the likelihood of a successful IND submission, allowing for timely advancement into clinical phases.
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Related Glossary
Orphan Drug Designation (ODD)
Target Product Profile (TPP)
Good Manufacturing Requirements (GMP)
Good Clinical Practice (GCP)
Applicant for Clinical Trial Applications (CTA)
Questions? Get the answers from our expert team
No two product development paths are the same. Talk to our experts about your development challenges and we will provide you actionable recommendations.