EXPERT GUIDANCE IN ORPHAN DRUG APPROVAL
Streamline Your Path to Market with Our FDA Approval Expertise.
Orphan Drug Designations (ODD)
Accelerated Regulatory Pathways
AI-Driven Molecule Development Support
EXPERT GUIDANCE IN ORPHAN DRUG APPROVAL
Streamline Your Path to Market with Our FDA Approval Expertise.
Orphan Drug Designations (ODD)
Accelerated Regulatory Pathways
AI-Driven Molecule Development Support
Achieving success through measurable results.
4 Months
Average Time to FDA ODD Designation
60+
FDA Registrations
93%
Client Satisfaction
$400M+
Our clients' revenue after approvals.
Main Services
03
AI-Driven Molecule Development Support
Our AI-Driven Molecule Development Support service is tailored for both startups and established laboratories. We assist in developing and presenting new molecules, including those created using artificial intelligence, for Orphan Drug designation (OD) with the FDA. Our comprehensive guidance through the regulatory process ensures your groundbreaking therapies reach those who need them most.
AI for Orphan Drug Discovery
Unlocking Breakthrough Therapies
From AI to Patients in Need
02
Accelerated Regulatory Pathways
The FDA's expedited programs aim to accelerate the development of certain drugs. Breakthrough Therapy Designation, Fast Track Designation, and Priority Review Voucher each require a specific designation to access their benefits, which Pharma 4.0 can help you secure. Accelerated Approval allows sponsors to achieve approval based on a surrogate endpoint. We also assist in preparing for meetings to gain approval for using a surrogate endpoint.
Fast Track Your Drugs Approvals
Endpoint Approval Strategy
Unlock FDA Fast Lane
01
Orphan Drug Designations (ODD)
Our Premier Service - We specialize in writing orphan drug designation (ODD) applications for FDA. Securing ODD provides sponsors with significant economic benefits, which vary based on whether the designation is obtained from the FDA.
ODD Designation Expertise
Global Application Support (FDA)
Maximize Orphan Drug Benefits
AI-Driven Molecule Development Support
Our AI-Driven Molecule Development Support service is tailored for both startups and established laboratories. We assist in developing and presenting new molecules, including those created using artificial intelligence, for Orphan Drug designation (OD) with the FDA. Our comprehensive guidance through the regulatory process ensures your groundbreaking therapies reach those who need them most.
AI for Orphan Drug Discovery
Unlocking Breakthrough Therapies
From AI to Patients in Need
Accelerated Regulatory Pathways
The FDA's expedited programs aim to accelerate the development of certain drugs. Breakthrough Therapy Designation, Fast Track Designation, and Priority Review Voucher each require a specific designation to access their benefits, which Pharma 4.0 can help you secure. Accelerated Approval allows sponsors to achieve approval based on a surrogate endpoint. We also assist in preparing for meetings to gain approval for using a surrogate endpoint.
Fast Track Your Drugs Approvals
Endpoint Approval Strategy
Unlock FDA Fast Lane
Orphan Drug Designations (ODD)
Our Premier Service - We specialize in writing orphan drug designation (ODD) applications for FDA. Securing ODD provides sponsors with significant economic benefits, which vary based on whether the designation is obtained from the FDA.
ODD Designation Expertise
Global Application Support (FDA)
Maximize Orphan Drug Benefits
AI-Driven Molecule Development Support
Our AI-Driven Molecule Development Support service is tailored for both startups and established laboratories. We assist in developing and presenting new molecules, including those created using artificial intelligence, for Orphan Drug designation (OD) with the FDA. Our comprehensive guidance through the regulatory process ensures your groundbreaking therapies reach those who need them most.
AI for Orphan Drug Discovery
Unlocking Breakthrough Therapies
From AI to Patients in Need
Accelerated Regulatory Pathways
The FDA's expedited programs aim to accelerate the development of certain drugs. Breakthrough Therapy Designation, Fast Track Designation, and Priority Review Voucher each require a specific designation to access their benefits, which Pharma 4.0 can help you secure. Accelerated Approval allows sponsors to achieve approval based on a surrogate endpoint. We also assist in preparing for meetings to gain approval for using a surrogate endpoint.
Fast Track Your Drugs Approvals
Endpoint Approval Strategy
Unlock FDA Fast Lane
Orphan Drug Designations (ODD)
Our Premier Service - We specialize in writing orphan drug designation (ODD) applications for FDA. Securing ODD provides sponsors with significant economic benefits, which vary based on whether the designation is obtained from the FDA.
ODD Designation Expertise
Global Application Support (FDA)
Maximize Orphan Drug Benefits
— Majo Villarraza
CEO & CO-FOUNDER
"Having been on the other side of the counter for more than 25 years and having launched more than 200 pharmaceutical, biologic, and orphan products in the USA, Europe, and LATAM, we understand the challenges of FDA approvals firsthand."
Find her on LinkedIn
Experience
+ 200 product launches to market.
Costs
< 10% More Competitive Costs than our High-end Competitors
Time
+ Faster Times to FDA ODD Designation
Results
More Than 95% Approvals
Experience
+ 200 product launches to market.
Costs
< 10% More Competitive Costs than our High-end Competitors
Time
+ Faster Times to FDA ODD Designation
Results
More Than 95% Approvals
Client Testimonials
❝
The team of Pharma 4.0 provided us with clear and comprehensive guidance, helping us navigate and understand the complex regulatory requirements for FDA approval with ease.
❝
The team of Pharma 4.0 provided us with clear and comprehensive guidance, helping us navigate and understand the complex regulatory requirements for FDA approval with ease.
❝
Pharma 4.0 delivered exceptional guidance throughout our FDA registration process. Their efficient and knowledgeable team ensured we met our objectives swiftly, significantly accelerating our project timeline
CEO in Alcomex Inc
❝
Pharma 4.0 delivered exceptional guidance throughout our FDA registration process. Their efficient and knowledgeable team ensured we met our objectives swiftly, significantly accelerating our project timeline
CEO in Alcomex Inc
❝
Pharma 4.0's expertise in FDA regulations was extremely helpful for our business development in the USA. Their in-depth knowledge saved us significant time and ensured a smooth process.
Founder in Ceibo Health LLC
❝
Pharma 4.0's expertise in FDA regulations was extremely helpful for our business development in the USA. Their in-depth knowledge saved us significant time and ensured a smooth process.
Founder in Ceibo Health LLC
❝
Thanks to Pharma 4.0, we swiftly navigated the FDA approval process. Their detailed and straightforward guidance allowed us to meet all regulatory requirements efficiently, enabling us to launch our products in the US market faster than we ever anticipated. Their professional support was instrumental in our rapid commercialization in USA
Director Laboratorios Abies
❝
Thanks to Pharma 4.0, we swiftly navigated the FDA approval process. Their detailed and straightforward guidance allowed us to meet all regulatory requirements efficiently, enabling us to launch our products in the US market faster than we ever anticipated. Their professional support was instrumental in our rapid commercialization in USA
Director Laboratorios Abies
— Majo Villarraza
CEO & CO-FOUNDER
"Having been on the other side of the counter for more than 25 years and having launched more than 200 pharmaceutical, biologic, and orphan products in the USA, Europe, and LATAM, we understand the challenges of FDA approvals firsthand."
Find her on LinkedIn
Experience
+ 200 product launches to market.
Costs
< 10% More Competitive Costs than our High-end Competitors
Time
+ Faster Times to FDA ODD Designation
Results
More Than 95% Approvals
Client Testimonials
❝
The team of Pharma 4.0 provided us with clear and comprehensive guidance, helping us navigate and understand the complex regulatory requirements for FDA approval with ease.
❝
Pharma 4.0 delivered exceptional guidance throughout our FDA registration process. Their efficient and knowledgeable team ensured we met our objectives swiftly, significantly accelerating our project timeline
CEO in Alcomex Inc
❝
Pharma 4.0's expertise in FDA regulations was extremely helpful for our business development in the USA. Their in-depth knowledge saved us significant time and ensured a smooth process.
Founder in Ceibo Health LLC
❝
Thanks to Pharma 4.0, we swiftly navigated the FDA approval process. Their detailed and straightforward guidance allowed us to meet all regulatory requirements efficiently, enabling us to launch our products in the US market faster than we ever anticipated. Their professional support was instrumental in our rapid commercialization in USA
Director Laboratorios Abies
Skilled regulatory professionals
We bring over 50 years combined of industry experience to help drug and device developers obtain FDA approvals. As seasoned regulatory professionals, we deeply understand the regulatory pathways in the rare and unmet medical in the USA and LATAM.
Tailored solutions
Every client is unique, as well as their projects. We professionally carve their uniqueness into the standardized FDA processes.
¿Struggling with FDA approvals?
¿Struggling with FDA approvals?
Confidence
Ensuring swift FDA approvals for your medical drugs and procedures.
Peace of Mind
If it is approvable, it will be approved under our guidance.
Celerity
Follow a time-tested system designed to fast-track your approvals.
No Roadblocks
We lift every liftable obstacle. Building highways to approvals is what we do.
Confidence
Follow a time-tested system designed to propel your company to new heights
Peace of Mind
Follow a time-tested system designed to propel your company to new heights
Financial Freedom
Follow a time-tested system designed to propel your company to new heights
No Challenges
Follow a time-tested system designed to propel your company to new heights
Our Process
Our Process
Our Process
The fastest pathway to approval
The fastest pathway to approval
The fastest pathway to approval
1
1
1
Initial Consultation
Initial Consultation
Initial Consultation
Introductory meeting with Pharma 4.0 - Orphan Drug Designation to discuss your regulatory strategy and objectives.
Introductory meeting with Pharma 4.0 - Orphan Drug Designation to discuss your regulatory strategy and objectives.
2
2
2
Confidentiality Agreement
Confidentiality Agreement
Confidentiality Agreement
Evaluate your data for eligibility and proceed under a Confidentiality Agreement (CDA) with Pharma 4.0 - ODD.
Evaluate your data for eligibility and proceed under a Confidentiality Agreement (CDA) with Pharma 4.0 - ODD.
3
3
3
Proposal Evaluation and Signing
Proposal Evaluation and Signing
Proposal Evaluation and Signing
Review the detailed proposal from Pharma 4.0 - ODD. Sign the agreement to begin collaboration.
Review the detailed proposal from Pharma 4.0 - ODD. Sign the agreement to begin collaboration.
4
4
4
Project Kick-off
Project Kick-off
Project Kick-off
Discuss the project timeline and data requirements in the initial meeting. Access to the Pharma 4.0 - ODD data room is provided.
Discuss the project timeline and data requirements in the initial meeting. Access to the Pharma 4.0 - ODD data room is provided.
5
5
5
Initial Draft Review
Initial Draft Review
Initial Draft Review
Pharma 4.0 - ODD will help your team to create and review the initial proposal draft before submitting to FDA/EMA.
Pharma 4.0 - ODD will help your team to create and review the initial proposal draft before submitting to FDA/EMA.
6
6
6
Submission of Final Draft
Submission of Final Draft
Submission of Final Draft
Finalize and submit the draft to FDA and/or EMA within 3-4 weeks of signing the proposal.
Finalize and submit the draft to FDA and/or EMA within 3-4 weeks of signing the proposal.
7
7
7
FDA Regulatory Decision
FDA Regulatory Decision
FDA Regulatory Decision
Receive the decision from FDA. Review for ODD applications typically takes 3-6 months.
Receive the decision from FDA. Review for ODD applications typically takes 3-6 months.
How we can help you
Services That We Offer
Services That We Offer
Benefit from a proven system that helps drug and device developers obtain FDA approval.
Development Strategy
01
Strategic reviews of application and pipeline
...
06
Strategic reviews of application and pipeline
...
01
Strategic reviews of application and pipeline
...
02
Regulatory strategy development
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07
Regulatory strategy development
...
02
Regulatory strategy development
...
03
Regulatory and clinical due diligence for a product
...
08
Regulatory and clinical due diligence for a product
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03
Regulatory and clinical due diligence for a product
...
04
IND- and NDA-enabling gap analysis
...
08
IND- and NDA-enabling gap analysis
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04
IND- and NDA-enabling gap analysis
...
05
CMC review and guidance
...
08
CMC review and guidance
...
05
CMC review and guidance
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Regulatory Submissions
06
Orphan Drug Designation (ODD)
...
06
Orphan Drug Designation (ODD)
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06
Orphan Drug Designation (ODD)
...
07
Accelerated process: Fast Track Designation (FTD)
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07
Accelerated process: Fast Track Designation (FTD)
...
07
Accelerated process: Fast Track Designation (FTD)
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08
Breakthrough Therapy Designation (BTD)
...
08
Breakthrough Therapy Designation (BTD)
...
08
Breakthrough Therapy Designation (BTD)
...
09
FDA meeting [Type A, B, C] preparation and attendance
...
08
FDA meeting [Type A, B, C] preparation and attendance
...
09
FDA meeting [Type A, B, C] preparation and attendance
...
10
IND preparation and submission
...
08
IND preparation and submission
...
10
IND preparation and submission
...
WHO WE ARE?
Pharma 4.0 LLC is a mission-driven corporation to using our FDA and LATAM regulatory expertise and knowledge of various therapeutics areas to help drug and device developers advance treatments for the disease communities with high unmet medical need.
We have assembled a team of the Americas-recognized experts in the rare diseases and other under-served disease areas. We maintain a completely customer-centric, transparent process through the entirety of our projects.
CEO - US FDA Agent
CEO - US FDA Agent
CEO - US FDA Agent
Quality & Public Affairs Director
Quality & Public Affairs Director
Quality & Public Affairs Director
Regulatory Affairs Director
Regulatory Affairs Director
Regulatory Affairs Director
Project Management Director
Project Management Director
Project Management Director
Members of
Spain-US Chamber
of Commerce
Argentine American Chamber of Commerce
Upgrade your Experience with Pharma 4.0
Contact Us
Schedule a call with Majo Villarraza
Schedule a call with
Majo Villarraza
