Bio-Chem offers various consulting services to companies in the pharmaceutical, medical, food, digital health and dietary and cosmetic supplement industries.
We advise and guide our customers, from 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 and registering products, performing validation and verification, coordinating adoption of international GxP requirements and guidelines, 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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Regulation & Registration

Software & Systems

Quality Validation & GxP

Regulation & Registration

  • Global regulatory strategy
  • Technical file

  • Regulatory classification rationale

  • Label and packaging design and text
  • Risk analysis and risk assessment
  • GMP, ISO 13485, FDA 21 CFR 820
  • IMOH, FDA, CE product registrations

  • Stability studies and shelf life
  • Subcontractor inspections and audits

  • Importer registration in Israel
  • Validation and verification (V&V)

  • Product registration renewals

  • Clinical trials in Israel

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Software & Systems

  • Digital, e-Health & medical software

  • ISO 27001, ISO 27799 certification

  • Software risk assessment

  • Data integrity & ALCOA

  • HIPAA & GDPR compliance

  • Medical software QA

  • 21 CFR Part 11 & EU Annex 11

  • Software verification & validation

  • ERP system validation

  • Software CE Mark & FDA 510K

  • CVS & 21 CFR Part 11 training

  • Backup, restore & recovery procedures

  • Track & Trace projects

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Quality Validation & GxP

  • GxP & ISO quality systems

  • Quality training

  • Policies & procedures

  • Quality improvement projects

  • Risk analysis & risk assessments

  • Annual GMP training

  • Pre-inspection QS audit & gap analysis

  • Vendor audits in Israel

  • Regulatory inspection preparations

  • Validation projects

  • QA & validation services

  • QP & QPPV services

  • ISO 27001, ISO 17025 & ISO 27799

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Design & Engineering

Manufacturing & Packaging

Research & Development

Design & Engineering

  • Designing production facilities

  • Laboratory design

  • BOD/URS writing & approval

  • Engineering project management

  • Clean rooms design

  • Site master file

  • Technology consulting

  • GEP/GMP/EHS consulting

  • Commissioning & validations

  • Preparation for GMP audits

  • Prototype design

  • Design control

  • FAT & SAT

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Manufacturing & Packaging

  • Manufacturing process development

  • Novel technologies consulting

  • Process engineering

  • Process & cleaning validation

  • Manufacturing instructions & procedures

  • 5S, Lean projects

  • Troubleshooting & improvements

  • Employee training

  • Annual GMP training

  • Clean room & gowning training

  • Preparation for external  audits

  • URS & design review

  • Equipment GMP & sanitary design

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Research & Development

  • Product development
  • Product market analysis
  • Commercialization strategy
  • Business & regulatory strategies
  • Business plan
  • Clinical trials in Israel

  • Risk analysis & risk assessment
  • Novel technologies & scale-up
  • Labs & clean rooms design

  • GLP & ISO 17025 certification

  • CMC writing

  • Stability studies

  • Due diligence consulting

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Our areas of expertise

Services - Bio Chem
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What do our customers say?

Services - 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
Services - 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
Services - 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
Services - 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
Services - 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
Services - 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
Services - 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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