BIOCHEM-LOGO
Eran Yona's website
אתר ביו-כם בעברית
Call an expert:

972-51-500-1353

Risk Assessment Document Templates

Quiz

Showing all 3 results

Your needs – Our proven regulation and personal capabilities

Bio-Chem Ltd. (2007) supports Bio-Med clients worldwide with quality, regulation, information security, validation, controlled documents, and much more.

Bio-Chem holds an unmatched 99% success rate of regulatory approvals for nearly two decades in the most challenging Bio- Pharma, Medical and Digital Health industries

GXP | ISMS | ISO | MEDICAL CANNABIS | QMS | RISK ASSESSMENT | VALIDATION | CONSULTATION

To schedule a consultation without obligation, click here or call:

051-500-1353

fILL details in the form and we will get back to you within a business day

Your document was not approved?

We offer our document review services by our senior consultants at a fraction of the cost you would normally pay or a full refund.

If you struggle to complete your application we offer additional support and advice for all your regulatory needs.

  • Professional support, including mock audit and Q&A sessions
  • Clear instructions for document customization for your specific needs
  • Final review by our in-house experts before final approval
  • Customised document writing based on specific needs

We have attained our expertise over 15 years of proven international regulatory and consultancy capabilities, gained via over 1000 projects!

Benefits when using our templates:

  • Best methodology and practice that fits your industry, products, and regulatory requirements
  • Have a template that is being used daily by our consultants in international FDA/CE/Eu audits
  • Improve your regulatory documents writing capabilities
  • Prepare your documents, based on smart & easy to use document templates and formats
  • Based on more than 1000 different projects in the Eu, US, Japan, Canada, and Israel
  • Fits FDA, Eu, ISO 13485, ISO 14971, HIPAA, GDPR, ISO 3100 regulations ​
  • Proven in various FDA, CE,TGA, ISO, Eu inspections
  • A versatile template that fits all Pharma/ Medical/
    E-Health/ Supplements and other industries
+ 0
years of experience
+ 0
customers Worldwide
% 0
customers coming back
% 0
Approvals success regulatory

Our unique work methodology, which was developed based on many years of experience in the industry, combines professional and practical knowledge, minimizes regulatory and business risks, improves productivity and returns for the client

More on us

Application Review

Use our experts to exam your application – Simply contact us with details and attach your document below: