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FABEL BIOPHARM TECH SERVICES

Proven Results

At FABEL consulting, we offer every client a personalized service to meet your specific needs.  We can also provide emergency service in short notice.

Petri Dishes

INTRODUCTORY CONSULTATION

Looking to develop your business but not sure where to turn? Need help planning or executing your next project? Let us guide you. Any organization can move forward with small incremental changes, but building for the future in today’s rapidly evolving environment means taking bold chances and making insightful decisions.

FABEL consulting can provide you a one-stop service for your technical solutions including: technology and product development, regulatory affairs and global product submissions, GXP and non-GXP quality services, manufacturing problem solving, analytical support, compliance audits and training for your staff.

Pipetting Samples and Test Tube
STRATEGIC PLANNING SESSION

We examine what organizations are doing to stay relevant and competitive in this fast-paced world, and which ones are doing it best. We then strategize using smart tools and global resources in order to understand the implications of every choice our clients can make. Get in touch to learn more about how this service can help you.

Our Experience:


  • Regulatory Affairs


  • Regulatory compliance (risk-based approach)


  • Quality systems development


  • QA audits (CAPA focused)


  • Full GMP compliance programs


  • FDA pre-approval inspections


  • FDA problem resolutions – 483s, warning letters


  • Due diligence (Third-Party and Technology)


  • Drug development


  • Competitor consumer product analysis


  • Formulation design and optimization


  • Poorly soluble compound and bio-enhancement


  • Full product lifecycle management from Discovery, Development, Marketing and Supply


  • Contract Research / Manufacturing Organizations (CROs/CMOs)


  • Technology transfer


  • Manufacturing scale up and troubleshooting


  • Product and process validation


  • Analytical method development and validation


  • Stability


  • Technical writing


  • Cosmetics, chemicals, foods and nutrition

Please visit our “Service Directory” to view a full list of our services.

Microscope
INTRODUCTORY CONSULTATION

Looking to develop your business but not sure where to turn? Need help planning or executing your next project? Let us guide you. Any organization can move forward with small incremental changes, but building for the future in today’s rapidly evolving environment means taking bold chances and making insightful decisions.

FABEL consulting can provide you a one-stop service for your technical solutions including: technology and product development, regulatory affairs and global product submissions, GXP and non-GXP quality services, manufacturing problem solving, analytical support, compliance audits and training for your staff.

STRATEGIC PLANNING SESSION

We examine what organizations are doing to stay relevant and competitive in this fast-paced world, and which ones are doing it best. We then strategize using smart tools and global resources in order to understand the implications of every choice our clients can make. Get in touch to learn more about how this service can help you.

Our Experience:


  • Regulatory Affairs


  • Regulatory compliance (risk-based approach)


  • Quality systems development


  • QA audits (CAPA focused)


  • Full GMP compliance programs


  • FDA pre-approval inspections


  • FDA problem resolutions – 483s, warning letters


  • Due diligence (Third-Party and Technology)


  • Drug development


  • Competitor consumer product analysis


  • Formulation design and optimization


  • Poorly soluble compound and bio-enhancement


  • Full product lifecycle management from Discovery, Development, Marketing and Supply


  • Contract Research / Manufacturing Organizations (CROs/CMOs)


  • Technology transfer


  • Manufacturing scale up and troubleshooting


  • Product and process validation


  • Analytical method development and validation


  • Stability


  • Technical writing


  • Cosmetics, chemicals, foods and nutrition

Please visit our “Service Directory” to view a full list of our services.

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