At Konexio Biotech we know that biotechnological products are the basis of future medicine. This is why we seek to unite two great worlds: BIOMEDICAL RESEARCH and the PHARMACEUTICAL INDUSTRY. This is the only connection that will allow us to move forward and create innovative products that will help the patients of today and tomorrow.
Therefore, in our team we have multiple profiles, scientific professionals who are experts in advanced therapies, molecular and cellular biology, biological analytical techniques (flow cytometry, PCR, sequencing and so on), bioinformatics, biostatistics and omic sciences (proteomics, genomics, epigenomics and metabolomics).
As well as experts in the most technical areas of the pharmaceutical industry: Quality and Compliance, Registries, Preclinical, Clinical Trials, Pharmacovigilance, Pharmaceutical Engineering and Market Access.
1.Biopharmaceutical, Start-up y Spin-off:
·Design or renovate your facilities and equip them.
·Design and execute the preclinical and clinical trials that your product requires based on the applicable regulations.
·Design and develop the regulatory strategy that your product needs.
·Train your staff as scientists in pharmaceutical regulations (GxP training).
·Help you with market access of your product.
·Seek external financing.
·Validate your analytical methods and support your process validations and qualification of both equipment and facilities.
·Conduct medical information audits of your promotional material.
2.Pharmaceutical company/cosmetic or medical device product manufacturer:
·Design the biotechnological product that best suits your business plan.
·Renew your installations and select the equipment you need.
·Implement the tech transfer strategy that your product requires.
·Train your staff whether they possess technical or commercial profiles.
·Design the preclinical and clinical strategy that your product requires.
·Carry out the regulatory strategy for your product
(IVDR, MDR, PIF, CTD...)
·Design the market access of your product.
·Carry out specific audits of biotech suppliers.
3.Research foundation, hospital or charity:
·Design the facilities and the quality plan that best suits your product.
·Evaluate your preclinical and clinical trials based on the applicable regulations.
·Design and develop the regulatory strategy that your product needs.
·Train your scientific staff in pharmaceutical regulations (GxP training).
·Validate your analytical methods and support your process validations and qualification of both equipment and facilities.
4.University and education centers:
·We help you to update your training plans as you move towards the biotechnology sector.
5.Investment fund and private investor:
·We help you to analyze the viability of your potential biotechnological projects technically and financially.
Thanks to our 360° service, we accompany you throughout the entire process: we design the biotechnological product that best suits your needs, we design your business plan, we implement a technology transfer strategy, we train to your staff so that they are qualified, we analyze and develop a preclinical, clinical and regulatory strategy for your product and, finally, we help you place your product on the market.
1.Biopharmaceutical, Start-up y Spin-off
2.Pharmaceutical company/cosmetic or medical device product manufacturer
3.Research foundation, hospital or charity
4.University and education centers
5.Investment fund and private investor
