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
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
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
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
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
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
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”
“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!”
“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”
“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.”
“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 ”
“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”
“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.”
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