Services2020-08-05T11:22:52+00:00

Our consulting services

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, adapting companies to 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.

To contact us for an appointment, please click here!

Regulation & Registration

Software & Systems

Quality Validation & GxP

רגולציה ורישום

  • Global regulatory strategy
  • Technical file

  • Regulatory classification rational

  • Label & packaging design and text
  • Risk analysis & risk assessment
  • GMP, ISO 13485, FDA CFR 820
  • Product registration is IMOH, FDA, CE
  • Stability study&Shelf life
  • Subcontractors inspection and audits

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

  • Product registration renewals

  • Clinical trials in Israel

For further details

תוכנה ומערכות

  • Digital, E-Health & Medical software

  • ISO 27001, ISO 27799 certification

  • Software risk assessment

  • Data integrity & ALCOA

  • HIPAA & GDPR compliance

  • Medical software QA

  • 21CFR Part 11 & Aneex11

  • Software verification & validation

  • ERP system validation

  • Software CE Mark & FDA 510K

  • CVS&21CFR part 11 training

  • Backup, restore & Recovery procedures

  • Track & Trace projects

For further details

איכות ולידציה ו-GxP

  • GXP/ISO quality systems

  • Quality trainings

  • 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

For further details

Design & Engineering

Manufacturing & Packaging

Research & Development

תכנון והנדסה

  • 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

  • Preparations towards GMP audit

  • Prototype design

  • Design control

  • FAT & SAT

For further details

ייצור ואריזה

  • Manufacturing process development

  • Novel technologies consulting

  • Process engineering

  • Process & Cleanig validation

  • Manufacturing instructions & Procedures

  • 5S, Lean projects

  • Troubleshooting & improvements

  • Employees trainings

  • Annual GMP training

  • Clean room & Gowning training

  • Preparation towards external  audits

  • URS & Design review

  • Equipment GMP and sanitary design

For further details

מחקר ופיתוח

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

  • Risk analysis & Risk assessment
  • Novel technology & scale up
  • Labs & Clean room design

  • GLP & ISO 17025 certification

  • CMC writing

  • Stability studies

  • Due diligence consulting

For further details

Our areas of expertise

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.”

Inbal Kapry Barel Sigma Aldrich
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