Regulation & registration2021-09-09T04:44:58+00:00

Bio-Chem offers various consulting services in various fields to companies in the pharmaceutical, medical, food, digital health and dietary and cosmetic supplement industries. We advise and guide our customers, as early as the product development stage, with selecting the most appropriate technology, building product and technical portfolios, establishing the quality system, providing training and obtaining certifications, submissions to health authorities, registering  products, performing validation and verification, adapting companies to international GxP requirements and guidelines compliance, solving technological and process problems and guiding risk management. We see great importance in providing professional, cost-effective and efficient service to our customers, without compromising on quality.
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How can we help in regulation & registration?

  • Global regulatory strategy
  • Label design and packaging
  • Formulation tests for products
  • Product registration
  • Shelf life determination
  • Preparing a product portfolio
  • Subcontractor certification

  • Importer registration
  • Planning and establishing commercial homes

  • Product registration renewal

For more regulation & registration services
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Our areas of expertise

Regulation & registration - Bio Chem
Regulation & registration - Bio Chem
Regulation & registration - Bio Chem
Regulation & registration - Bio Chem
Regulation & registration - Bio Chem
Regulation & registration - Bio Chem

What do our customers say?

Regulation & registration - Bio Chem

“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
Regulation & registration - Bio Chem

“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
Regulation & registration - Bio Chem

“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
Regulation & registration - Bio Chem

“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
Regulation & registration - Bio Chem

“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
Regulation & registration - Bio Chem

“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
Regulation & registration - Bio Chem

“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.”

Inbal Kapry Barel, Sigma Aldrich
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