Step by step Regulatory Roadmaps for Multiple Countries in one place

Drug Composition Input

Enter your drug composition details to receive licensing requirements across different countries.

Name of the Pharmaceutical Company

Application Type *

NDA (New Drug Application)

IND (Investigational New Drug)

Drug Name *

Drug Type *

Stage of the Molecular Study *

Preclinical

Phase 1

Phase 2

Phase 3

Phase 4

Description of the Substance

Active Ingredients *

Include all Active Pharmaceutical Ingredients (APIs) with their exact quantities and units.

Name*

Molecular Formula

SMILES

Quantity*

Name*

Molecular Formula

SMILES

Quantity*

Name*

Molecular Formula

SMILES

Quantity*

Excipients

List all inactive ingredients that serve as vehicles, binders, or preservatives.

Name

Molecular Formula

SMILES

Purpose

Name

Molecular Formula

SMILES

Purpose

Preclinical Data – Pharmacokinetics

Toxicology Information

Route of Administration *

Therapeutic Class *

Is it a flagged application? *

Flag any controlled substances or ingredients with special regulatory considerations.

Yes

Is a Risk Management Plan required?

Yes

Is a Pediatric Management Plan required?

Yes

Target Countries for Approval *

Select all target markets to receive comprehensive approval requirements for each jurisdiction.

United States

European Union

United Kingdom

Canada

Japan

Australia

Brazil

China

India

Additional Notes

How it works

OntoPharma analyzes your drug composition and identifies the licensing requirements across multiple countries, saving you time and ensuring compliance.

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1.Enter your drug's composition details
2.Select target countries for approval
3.Review the AI-generated licensing steps
4.Export detailed requirements for each market