Despite political, technological and social changes which have occurred in the last decade, the biopharmaceutical field is still one of the most important when it comes to maintaining public health, quality of life and even a regular lifestyle, both in developing and developed countries.
The pharmaceutical and biotech sectors include companies engaged in the development and manufacture of drugs and medicinal products, which are used to prevent disease, detect, cure and relieve symptoms in humans and animals. The “main suppliers” of the pharmaceutical industry are companies that develop investigational drug substances and/or drug products. These products must pass different clinical stages, and may be registered and sold only after their safety and efficacy has been proven.
The many changes in recent years include mergers between “big pharma” companies, price pressure, relocation of production facilities to developing countries, and the COVID-19 pandemic in 2020. Nevertheless, the biopharmaceutical industry is considered very profitable and stable, and shows impressive growth rates.
The biopharmaceutical industry manufactures products for humans (most patients), and there are many risks involved. Thus, this industry is characterized by complex regulation and, as a result, complicated access barriers.
Several factors influence the success of the pharmaceutical industry, such as competition, political involvement, socio-cultural changes, technological advances, and regulation.
Israel is considered one of the world leaders in drug development and medical technologies, and in recent years we have witnessed the expansion of the field of medicine in many areas such as cellular therapy, genomic therapy, biological drugs, and preventive medicine, to name a few.
Our pharma & biotech consulting services
What do our customers say?
“Eran from Bio-Chem supported and Counseled Medimor Ltd. during transformation from antenna Manufacturer company named “Galtronics” to be a one of the leading Medical Device turnkey subcontractor in Israel. The project included state of the art clean rooms facility design and inspection, qualifications and GMP training. I enjoyed working with Eran and Bio-Chem team. They performed excellent professional work and were very committed to the project with the highest standards a customer can ask for. Eran and Bio-Chem Completed the project tasks in satisfactory quality level and in a timely manner”
Ofer Sagi, Quality Engineering manager at J&J
“I have used Bio-Chem, for external GMP inspection in one of our TEVA facilities. The inspection was done in a very professional manner by Bio-Chem team. The inspector was well skilled and experienced; and the inspection was thorough and efficient. Thank you!”
Dr. Gali Guzikevich, Sr. Director GMP QA, Innovative R&D, Teva
“Eran Yona performed two GMP and one ISO audits that evaluate our contractors. Excellent performance, deep cGMP/ISO knowledge, customer orientation and fasts communication characteristic. Final audit reports were provided during a really short time, and additional questions that I had were answered quickly and accurately. It would be a pleasure to work with Eran on any project again in the future”
Georgy Laskov, QP at Zoetis
“For the Bio-Chem team, working with you is professional and relevant, with a pleasant and courteous reference. On this occasion, we thank you for your support throughout the period we work together, and we would love to recommend Bio-Chem as an excellent and professional company.”
Dr. Yael Koresh, QA Minipac
“Many thanks to Eran Yona and the Bio-Chem staff. The staff was invited on a short notice to a new facility, the work was done professionally while meeting very tight and rigid schedules. Professional team with lots of patience and courtesy. I would love to recommend Biochem as an excellent and professional company ”
Simha Vazana, QA Manager Phibro
“Eran Yona and Bio-Chem has many years of experience in industrial pharmaceuticals from design to construction, validation and GMP manufacturing. In all our interactions I was very satisfied with their recommendations and practical suggestions. They helped the companies I was involved with to overcome practical manufacturing and regulatory obstacles”
Adrian Harel, CEO at Medicortex Finland Oy
“Eran Yona and the Bio-Chem team have consulted for Sigma Aldrich on GMP and Validations towards an FDA regulatory inspection. The company was professional and service-oriented throughout the entire project. All documentation supplied was well written and detailed. Bio-Chem’s support has allowed our organization to complete the project on-time and successfully. Their guidance has improved our company’s regulatory compliance and manufacturing processes.”