Innovation1 Biotech

Physician-Directed Nutritional Solutions

Innovation1 Biotech’s medical food formulations are specifically developed for individuals with distinctive nutritional requirements that cannot be met through ordinary diet modification alone. Each formula is manufactured in our NSF GMP Registered facility and must be used under physician supervision as required by FDA regulations.

Clinical Therapeutic Categories

Post-Viral Syndromes

Medical nutrition targeting documented Long COVID metabolic dysfunction and persistent post-viral fatigue.

Reproductive Disorders

Physician-prescribed nutrition for PCOS, infertility, and documented reproductive metabolic disturbances.

Menopausal Dysfunction

Medical nutrition addressing documented estrogen metabolism disruption and menopausal transition disorders.

Metabolic Syndrome

Advanced medical nutrition for complex insulin resistance and multi-system metabolic dysfunction.

Autoimmune Conditions

Medical nutrition for documented immune dysregulation and inflammatory cascade disorders.

Neurode generative Disorders

Physician-supervised nutrition targeting documented cognitive decline and neurological dysfunction.

Medical Foods

METARESTORE™

Long COVID Support

Medical food formulated for individuals with documented metabolic disturbances associated with Long COVID syndrome that cannot be met through ordinary diet modification alone. Contains targeted mitochondrial support compounds, inflammatory modulators, and neurological cofactors in a physician-supervised formulation.

REPROBALANCE™

Fertility Formula

Medical food providing targeted nutritional support for women with documented metabolic disturbances affecting hormone balance and reproductive function. Contains specialized amino acids, methylation cofactors, and inositols in a physician-supervised formulation.

HORMONEESSENCE™

Menopausal Support

Medical food formulated for women with documented metabolic disturbances during perimenopause and menopause, supporting healthy estrogen metabolism, thermoregulation, and bone mineral density. Available only through healthcare practitioners.

Pharmaceutical-Grade Formulation

Innovation1 Bio medical foods are developed through a rigorous scientific process:

Metabolic Assessment

Comprehensive biomarker evaluation identifies specific metabolic pathway imbalances.

Facility Location

Targeted nutritional compounds selected based on objective biomarker data.

NSF Registration

Produced in certified cGMP facilities under strict quality control.

Standardized Potency

Each formulation contains precisely quantified nutritional compounds with verified bioactivity

Manufacturing Excellence Partnership

Pharmaceutical-Grade Medical Food Development Under Licensed Medical Oversight

Innovation1 Bio maintains an exclusive strategic partnership with Freedom to Formulate (Personalized & Compounded Nutrients, LLC), a premier NSF GMP registered medical food manufacturing facility specializing in physician-directed nutritional formulations. Located in Sisters, Oregon, this state-of-the-art facility operates under the highest pharmaceutical-grade standards to ensure every medical food formulation meets FDA regulatory requirements under 21 CFR 101.9(j)(8).

Licensed Healthcare Provider Integration

Prescription-Based Medical Food Development

All medical food formulations are developed and dispensed exclusively under the supervision of licensed healthcare practitioners in accordance with Legit Script certification standards. Our manufacturing partner, Freedom to Formulate, maintains an extensive network of licensed physicians, nurse practitioners, and healthcare providers who authorize all medical food prescriptions based on documented medical necessity.

Key Compliance Elements:

Licensed Practitioner Oversight

All medical foods require valid prescriptions from licensed healthcare providers.

Medical Necessity Documentation

Each formulation addresses specific medical conditions with distinctive nutritional requirements.

Prescription Verification Process

Comprehensive validation system ensures all prescriptions meet regulatory standards.

Healthcare Provider Network

Established relationships with licensed practitioners across multiple jurisdictions

NSF GMP Registered Manufacturing Excellence

Freedom to Formulate Facility Credentials

Our manufacturing partner operates under the most stringent pharmaceutical-grade quality standards:

NSF GMP Registration

National Sanitation Foundation Good Manufacturing Practices certification for dietary supplements and medical foods, ensuring compliance with FDA 21 CFR Part 111 regulations.

FDA Compliance

Full adherence to medical food regulations under 21 CFR 101.9(j)(8), including proper labeling, medical supervision requirements, and safety protocols.

Licensed Healthcare Provider Network

Established relationships with licensed practitioners who prescribe medical foods based on documented medical conditions.

HIPAA Compliance

Comprehensive protected health information protocols ensuring patient privacy throughout the prescription and fulfillment process.

Precision Manufacturing

Made-to-order compounding capabilities for individualized medical food formulations.

Patient Safety & Regulatory Compliance Framework

Comprehensive Medical Oversight Process

Our medical food development and distribution process maintains strict compliance with LegitScript healthcare certification standards:

Professional Prescription Documentation System

Sample Medical Food Prescription Process

Innovation1 Bio utilizes Freedom to Formulate's established prescription documentation system, which has been refined over 10+ years of serving healthcare practitioners. The standardized prescription form demonstrates our commitment to proper medical oversight and regulatory compliance.

Digital Prescription Processing

Freedom to Formulate's cloud-based digital formulator platform enables healthcare practitioners to create, submit, and track prescriptions through a secure, HIPAA-compliant system. This advanced technology ensures prescription accuracy while maintaining complete documentation for regulatory compliance and patient safety monitoring.

Prescription Authorization Process

Licensed Practitioner Assessment

Healthcare providers evaluate patients for medical conditions requiring specialized nutritional support.

Medical Necessity Documentation

Comprehensive clinical documentation establishing distinctive nutritional requirements.

Prescription Issuance

Valid prescriptions issued by licensed healthcare providers for specific medical foods.

Prescription Verification

Multi-step validation process ensuring prescription authenticity and regulatory compliance

Quality Assurance Protocols

Raw Material Qualification– Identity, purity, and potency verification for all ingredients
In-Process Testing– Multiple quality checkpoints throughout manufacturing
Finished Product Analysis– Comprehensive testing for potency, purity, and safety
Batch Documentation– Complete traceability records for regulatory compliance
Stability Testing– Shelf-life validation and efficacy maintenance verification

Patient Safety Measures

Adverse Event Reporting– Established protocols for monitoring and reporting patient responses
Healthcare Provider Communication– Direct channels for practitioners to address patient concerns
Contraindication Screening– Comprehensive evaluation of potential drug-nutrient interactions
Follow-Up Protocols– Systematic patient monitoring through healthcare provider network

HIPAA-Compliant Patient Services

Protected Health Information Management

All patient interactions and medical food prescriptions are managed through HIPAA-compliant systems ensuring complete protection of protected health information (PHI):

Secure Patient Portals

Encrypted communication channels for healthcare providers and patients.

PHI Protection Protocols

Comprehensive data security measures exceeding federal requirements.

Access Controls

Restricted access to patient information on need-to-know basis.

Audit Trails

Complete documentation of all PHI access and usage.

Business Associate Agreements

Formal HIPAA compliance agreements with all partners.

Licensed Practitioner Network

Medical Professional Oversight Structure

Our medical food program operates under the direct supervision of licensed healthcare professionals:

Medical Director

Board-certified physician providing clinical oversight of all medical food prescriptions.

Licensed Practitioners

Network of physicians, nurse practitioners, and healthcare providers authorized to prescribe medical foods in their respective jurisdictions

Clinical Assessment Team

Licensed professionals specializing in metabolic health and nutritional medicine.

Regulatory Compliance Officer

Dedicated personnel ensuring adherence to all federal and state regulations

Manufacturing Partner Transparency

Freedom to Formulate Facility Details

Licensed Practitioner Assessment

Personalized & Compounded Nutrients, LLC (dba Freedom to Formulate).

Facility Location

Sisters, Oregon.

NSF Registration

GMP Registered Facility.

Experience

10+ years serving healthcare practitioners.

Specialization

Physician-directed medical food compounding.

Regulatory Status

FDA-compliant medical food manufacturing.

Advanced Digital Formulation System

Cloud-based practitioner formulator platform
Real-time prescription processing and validation
Individual patient-specific formulations
450+ high-quality ingredient options
Automated compliance checking protocols

Manufacturing Capabilities

Made-to-order custom medical food development
Small-batch precision compounding (low minimum orders)
Individual patient-specific formulations
Triple-verification quality control testing
100% excipient/chemical filler-free options
Temperature-controlled storage and distribution
Independent third-party laboratory testing

Regulatory Compliance Documentation

Comprehensive Legal Framework

Our medical food operations maintain full compliance with all applicable regulations:

Federal Compliance

FDA Medical Food Regulations (21 CFR 101.9(j)(8))
HIPAA Protected Health Information Requirements
Federal Trade Commission Guidelines
DEA Controlled Substance Regulations (where applicable)

State Compliance

Licensed healthcare provider requirements in all operating jurisdictions
State pharmacy and compounding regulations
Professional licensing verification
Interstate commerce compliance

International Compliance

International operations compliance (Israel facility).
Cross-border prescription validation.
International patient privacy regulations.

Continuous Monitoring & Quality Assurance

Ongoing Compliance Verification

Our partnership with Freedom to Formulate includes continuous monitoring protocols ensuring sustained regulatory compliance:

Regular Facility Audits

Quarterly inspections of manufacturing processes.

Prescription Compliance Reviews

Ongoing validation of practitioner prescribing patterns.

Patient Safety Monitoring

Systematic tracking of patient outcomes and adverse events.

Regulatory Updates

Proactive monitoring of changing regulations and compliance requirements.

Staff Training Programs

Continuous education for all personnel handling medical foods

Patient Safety Commitment

Every medical food formulation produced through our manufacturing partnership with Freedom to Formulate carries the assurance of licensed medical supervision, pharmaceutical-grade quality standards, and comprehensive regulatory compliance. This commitment ensures that healthcare professionals and patients can trust in the safety, efficacy, and legal compliance of every product we deliver.

All medical foods must be used under the supervision of a physician for the dietary management of specific medical conditions. These products are not intended for general nutritional use.

Contact Information

Freedom to Formulate (Manufacturing Partner)

Sisters, Oregon
NSF GMP Registered Facility