Financial Services
We act through different financing options identifying bespoken solutions for any client if the minimum required conditions are met, involving in some cases accredited or non-accredited investors, often the creation of hybrid solutions in between available funding options is successful to the purpose.
Any opportunity will be ultimately introduced to our financial partners only after an accurate due diligence feasibility analysis will have considered it viable.
Projects who need financial support to allow take-off despite the fact they could not find financial sustain in traditional financial resources or who aren't always able to meet traditional or conforming financial regulations.
Biotech Licensing & M & A Consulting
Licensing strategies, strategic business development, diverse growth strategies like: Royalty & streaming, reverse merging, private placements for accredited investors & Due Diligence.
Leasing Bank Guarantee & Collateral Transfer in Europe/UK only
Collateral Transfer is a dynamic way of raising high-level capital to finance commercial enterprises and specific projects. It allows the Borrower to raise secured borrowings without encumbering existing assets, or where the Borrower holds inadequate assets and security for conventional lending requirements.
Allowing commercial enterprises that do not have adequate security for conventional lending facilities to raise capital swiftly for short to mid-term projects. Facilities start from €10 million till €500 million are available.
Raising Lines of Credit
Bank Guarantees that are received under Collateral Transfer facilities can be used by the recipient secure Lines of Credit at a bank. A bank typically will have no objection to offering credit against a Bank Guarantee which is received in this manner. Lending can be up to 100% of face value, less the advance of interest charged, and bank fees associated. However, typical lending rates are presumed to be between 80-90% of face value. The total term of credit can be for the duration of the Guarantee, between 1 – 5 years and will not exceed the expiry of the Guarantee.
What we offer
GMP Consulting - Services
Quality by design is an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines.
Quality by design centres on the use of multivariate analysis, often in combination with modern process-analytical chemistry methods and knowledge-management tools to enhance the identification and understanding of critical attributes of materials and critical parameters of the manufacturing process.
Our efficient and well-structured risk-based approach provides the right focus to ensure that your biotech products meet high-quality requirements.
QbD’s team offers knowledge & solutions in development, clinical, regulatory & compliance, production and distribution for companies active in ATMP, Biotech, Medical Devices, In Vitro Diagnostics and Pharma.
Regulatory Consulting - Services
We provide our clients unique and tailor-made support with European and US regulatory requirements. We offer expert guidance and know-how to optimise the time to market for your products.
Always an integral part of projects but often provided as a separate service are our quality control (QC) and quality assurance (QA) services.
We facilitate authority meetings, help you prepare the necessary briefing packages containing a full development strategy and accompany you in all phases of interactions with regulators including dossier preparation and full regulatory submissions.
Drug Discovery -Services
Hydrogen Deuterium Exchange Mass Spectrometry. Hydrogen Deuterium Exchange Mass Spectrometry (HDX MS) to provide label-free drug screening and crystal-free protein-structural services using a single and innovative analytical platform.
HDX MS analysis for mapping biomolecular interactions. We provide top-quality data for expedite characterisation of biomolecular binding interfaces and structural-based quality control, over our commercial available state-of the art platform.
Orthogonal screening for pharmaceutical discovery and development.
The current state of biophysical methods requires the use of a multitude of different techniques and expertise for ligand screening and binding site characterisation (e.g. Biacore (Biosensors), fluorescence, x-ray crystallography, NMR). In this context, we will provide the use of a single analytical platform to perform both analysis using label-free techniques that will provide a fast and cost-efficient service to our clients.
HDX MS can be used for ligand screening by monitoring areas related to the binding site. The LC-MS and data processing are tailored to interrogate a library of compounds to a target protein. The analysis can performed in samples containing almost any kind of biological buffers (e.g TRIS, BIS-TRIS, HEPES). HDX MS is routinely utilized to identify the binding site of small molecules to proteins, as well as for the characterization of binding interfaces between protein/protein and protein/peptide complexes.
Companion Diagnostics (CDx)-Services
Development and regulatory oversight in precision medicine, synchronising all CDx or IVD and biopharma development activities, as a single ‘start-to-finish’ partner to complete your FDA-approved companion diagnostic device.
Comply with the distinct regulations for both therapies and devices.
Therapeutic Product: Investigational New Drug, 21 CFR 312. IVD. Optimise clinical trial design to include investigation of IVD companion diagnostic device along with the therapy.
AI-driven healthcare solutions
Research & Development of DT Digital Therapeutics, Digital Transformation & AI Optimisation, AI-Driven Process Optimisation and Predictive Maintenance. Advanced data analytics, AI-driven models, and digital twin technologies to achieve operational excellence.
Predictive modelling, machine learning algorithms, and statistical process control (SPC). Validate models using cross-validation, sensitivity analysis, and stress testing. Integrate AI models with existing MES and ERP systems. ISPE Pharma 4.0 standards, GAMP 5 guidelines and ICH quality requirements.
Optimise Process performance. Enhance Predictive Capabilities. Ensure Regulatory Compliance. Drive Operational Excellence.
Data acquisition & preparation to consolidate data from ERP, MES, LIMS and PAT sensors. Model development: Gradient Boosting Machines (GBM), Random Forest, Convolutional Neural Networks (CNNs).
Digital Twin Implementation: A Digital Twin is a dynamic, virtual representation of a physical manufacturing process, continuously updated with real-time data. It enables real-time monitoring, predictive analytics, and process optimisation.
Medical Device Consulting
Design control and quality management system (QMS) implementation. FDA 510(k) and PMA submission preparation. Risk management and usability studies. Market entry and commercialisation strategies. Post-market surveillance (PMS) and reporting.
We are strongly committed in primary prevention and we are in the process of developing solutions to stay healthy in delaying the onset of the disease, with very early diagnostics and active solutions in Cancer, Neurodegenerative diseases, and in Cardiovascular diseases.
— Alternative thinking - prevention is preferable to cure!
Quote Professor Dr. Roman Zubarev in Alzheimer`s research:
„Delaying the onset of AD by 5 years would reduce the number of AD cases by half; delaying by 10 years will practically eliminate the disease as en epidemic phenomenon.“