Services
Simple, transparent proposals
We believe quality should be accessible to all companies, no matter the size.
Services
Simple, transparent proposals
We believe quality should be accessible to all companies, no matter the size.
Services
Simple, transparent proposals
We believe quality should be accessible to all companies, no matter the size.
Services
Simple, transparent proposals
We believe quality should be accessible to all companies, no matter the size.
GRAS
Includes
Evaluate ingredient safety
Build GRAS dossiers for GRAS (self-affirmed) and FDA notified GRAS.
Widespread experience in literature review and evaluation of scientific data for GRAS dossier preparation.
Risk Assessment
Includes
Preclinical review and assessment of data from safety toxicology studies.
Scientific risk assessment of issues
Regulatory strategy from pilot stage
Provision of toxicology solutions for food safety.
Consulting
Includes
Feasibility/preclinical assessments
Safety and toxicology data assessment on whole foods, food ingredients, and innovative food products.
Assistance with food safety/toxicology information/reports/scientific publishing
GRAS
Includes
Evaluate ingredient safety
Build GRAS dossiers for GRAS (self-affirmed) and FDA notified GRAS.
Widespread experience in literature review and evaluation of scientific data for GRAS dossier preparation.
Risk Assessment
Includes
Preclinical review and assessment of data from safety toxicology studies.
Scientific risk assessment of issues
Regulatory strategy from pilot stage
Provision of toxicology solutions for food safety.
Consulting
Includes
Feasibility/preclinical assessments
Safety and toxicology data assessment on whole foods, food ingredients, and innovative food products.
Assistance with food safety/toxicology information/reports/scientific publishing
GRAS
Includes
Evaluate ingredient safety
Build GRAS dossiers for GRAS (self-affirmed) and FDA notified GRAS.
Widespread experience in literature review and evaluation of scientific data for GRAS dossier preparation.
Risk Assessment
Includes
Preclinical review and assessment of data from safety toxicology studies.
Scientific risk assessment of issues
Regulatory strategy from pilot stage
Provision of toxicology solutions for food safety.
Consulting
Includes
Feasibility/preclinical assessments
Safety and toxicology data assessment on whole foods, food ingredients, and innovative food products.
Assistance with food safety/toxicology information/reports/scientific publishing
GRAS
Includes
Evaluate ingredient safety
Build GRAS dossiers for GRAS (self-affirmed) and FDA notified GRAS.
Widespread experience in literature review and evaluation of scientific data for GRAS dossier preparation.
Risk Assessment
Includes
Preclinical review and assessment of data from safety toxicology studies.
Scientific risk assessment of issues
Regulatory strategy from pilot stage
Provision of toxicology solutions for food safety.
Consulting
Includes
Feasibility/preclinical assessments
Safety and toxicology data assessment on whole foods, food ingredients, and innovative food products.
Assistance with food safety/toxicology information/reports/scientific publishing
FAQs
Everything you need to know about the product and billing. Can’t find the answer you’re looking for? Please chat to our friendly team.
What is the average time to complete a GRAS dossier?
On average it takes about fourteen weeks to complete a GRAS dossier after data/information is provided. This may vary during peak holiday times.
Does self-GRAS with expert panel sign-off provide pre-market authorisation for an ingredient?
Yes, it does and allows the manufacturer of the ingredient/product to market it within the limits specified by the GRAS
What information is key to get the GRAS dossier initiated?
Although this depends on the type of the ingredient, any and all information pertaining to the safety of the ingredient/product will be key to initiate the GRAS monograph.
How long does it take to get the Expert panel to sign off on the GRAS?
It takes at least a month to complete the review, provided the dossier is completed and is not provided to the experts during peak holiday times (Mid Nov – early Jan).
What is the difference between Self-GRAS and FDA notified or Full GRAS?
A Self-GRAS is often proprietary in nature and stays with the client/manufacturer of the ingredient/product, while FDA notified GRAS will be made public and will reside in the FDA GRAS inventory of substances/archives.
What information is a must to get the GRAS dossier completed?
Provision of specifications through the certificate of analysis from three to five non-consecutive batches of the ingredient/product
FAQs
Everything you need to know about the product and billing. Can’t find the answer you’re looking for? Please chat to our friendly team.
What is the average time to complete a GRAS dossier?
On average it takes about fourteen weeks to complete a GRAS dossier after data/information is provided. This may vary during peak holiday times.
Does self-GRAS with expert panel sign-off provide pre-market authorisation for an ingredient?
Yes, it does and allows the manufacturer of the ingredient/product to market it within the limits specified by the GRAS
What information is key to get the GRAS dossier initiated?
Although this depends on the type of the ingredient, any and all information pertaining to the safety of the ingredient/product will be key to initiate the GRAS monograph.
How long does it take to get the Expert panel to sign off on the GRAS?
It takes at least a month to complete the review, provided the dossier is completed and is not provided to the experts during peak holiday times (Mid Nov – early Jan).
What is the difference between Self-GRAS and FDA notified or Full GRAS?
A Self-GRAS is often proprietary in nature and stays with the client/manufacturer of the ingredient/product, while FDA notified GRAS will be made public and will reside in the FDA GRAS inventory of substances/archives.
What information is a must to get the GRAS dossier completed?
Provision of specifications through the certificate of analysis from three to five non-consecutive batches of the ingredient/product
FAQs
Everything you need to know about the product and billing. Can’t find the answer you’re looking for? Please chat to our friendly team.
What is the average time to complete a GRAS dossier?
On average it takes about fourteen weeks to complete a GRAS dossier after data/information is provided. This may vary during peak holiday times.
Does self-GRAS with expert panel sign-off provide pre-market authorisation for an ingredient?
Yes, it does and allows the manufacturer of the ingredient/product to market it within the limits specified by the GRAS
What information is key to get the GRAS dossier initiated?
Although this depends on the type of the ingredient, any and all information pertaining to the safety of the ingredient/product will be key to initiate the GRAS monograph.
How long does it take to get the Expert panel to sign off on the GRAS?
It takes at least a month to complete the review, provided the dossier is completed and is not provided to the experts during peak holiday times (Mid Nov – early Jan).
What is the difference between Self-GRAS and FDA notified or Full GRAS?
A Self-GRAS is often proprietary in nature and stays with the client/manufacturer of the ingredient/product, while FDA notified GRAS will be made public and will reside in the FDA GRAS inventory of substances/archives.
What information is a must to get the GRAS dossier completed?
Provision of specifications through the certificate of analysis from three to five non-consecutive batches of the ingredient/product
FAQs
Everything you need to know about the product and billing. Can’t find the answer you’re looking for? Please chat to our friendly team.
What is the average time to complete a GRAS dossier?
On average it takes about fourteen weeks to complete a GRAS dossier after data/information is provided. This may vary during peak holiday times.
Does self-GRAS with expert panel sign-off provide pre-market authorisation for an ingredient?
Yes, it does and allows the manufacturer of the ingredient/product to market it within the limits specified by the GRAS
What information is key to get the GRAS dossier initiated?
Although this depends on the type of the ingredient, any and all information pertaining to the safety of the ingredient/product will be key to initiate the GRAS monograph.
How long does it take to get the Expert panel to sign off on the GRAS?
It takes at least a month to complete the review, provided the dossier is completed and is not provided to the experts during peak holiday times (Mid Nov – early Jan).
What is the difference between Self-GRAS and FDA notified or Full GRAS?
A Self-GRAS is often proprietary in nature and stays with the client/manufacturer of the ingredient/product, while FDA notified GRAS will be made public and will reside in the FDA GRAS inventory of substances/archives.
What information is a must to get the GRAS dossier completed?
Provision of specifications through the certificate of analysis from three to five non-consecutive batches of the ingredient/product
Still have questions?
Can’t find the answer you’re looking for? Contact our friendly team.
Still have questions?
Can’t find the answer you’re looking for? Contact our friendly team.
Still have questions?
Can’t find the answer you’re looking for? Contact our friendly team.
Still have questions?
Can’t find the answer you’re looking for? Contact our friendly team.
Book your free consultation call now!
Click on the get started button below to schedule your free 15 minute consultation call.
Book your free consultation call now!
Click on the get started button below to schedule your free 15 minute consultation call.
Book your free consultation call now!
Click on the get started button below to schedule your free 15 minute consultation call.
Book your free consultation call now!
Click on the get started button below to schedule your free 15 minute consultation call.