ABOUT
BelLA green Pharma

Passionate About Succeeding

At Bella Green Pharma, we understand that change is not always easy. Since our founding, we’ve been helping companies of all sizes respond to industry transitions in order to stay competitive. Our combined years of experience have taught us to always make your business success our priority. Our team of experts is ready to help you develop strategies for not only surviving, but thriving in the future. Give us a call today to set up your first consultation.

The drug and therapy development process often involves starts, stops, delays and do-overs. First time success requires an experienced team of development specialists who can provide a clear and proven roadmap. Staying on schedule requires the perfect mix of technical knowledge, practical business experience and broad regulatory compliance understanding – all supported by a culture of precise execution.

With CBD, Hemp, Essential Oils & Homeopathic products now becoming regulated by the FDA, you may quickly become overwhelmed trying to navigate the complex federal regulations with which you must now comply. Our talented professionals will help you make this transition seamlessly. Companies like yours, that have been doing a good job of self-regulation, should not be impacted by time consuming processes that will lead to lost revenue and possibly fines. We want to help you complete this process as quickly and effectively as possible so you can focus on what you do best, which is making your products. With our assistance and guidance you can save time and money!

What We Do

Phase 1: Company Registration

Register your company with a NDC Number (national drug code number)
Register your company's manufacturing facilities with a FDA FEI (federal entity identifier)
Create an access portal for your company with the FDA's Center for Drug Evaluation and Research

Phase 2: Company Evaluation

Review each product made by your company and identify appropriate OTC monographs, therapeutic monographs & medical claims
Review product labels to ensure compliance under the Federal Food, Drug, and Cosmetic Act
Create internal product codes and package codes for NDC compliance

Phase 3: Product Submission

Submit each of your products through the FDA system for approval
Verify any medical claims for each listing and submit each new label with your NDC number
Reserve NDC numbers for future projects

The Process

01

Consultation with Bella Green Pharma

Once a Mutual Non Disclosure Agreement has been signed, we discuss the objectives of your company. This is where you will disclose information pertinent for us to make recommendations for your next step.

02

Follow-up & Contracts

In our follow-up meeting, we will discuss all of the options available to your company in order to pursue FDA certified facilities, drugs and products. We will outline the necessary steps specific to your company and set milestones. If your company chooses to move forward, with the process we've outlined, a signed and accepted contract with initial payment will be required for Bella Green Pharma to proceed with the identified projects.

03

Facility Registration & NDC number assignment

When all the necessary paperwork been signed and accepted, the process of registering your company and its facilities with the Center for Drugs Evaluation and Research begins. This is required in order to obtain an FEI and NDC.

04

Product Registrations & Compliance Consulting

While your company is awaiting FDA acceptance, Bella Green Pharma begins the process of ascertaining that all of the necessary information has been provided for the individual products that you have requested to be registered. We will ensure that all labels to be created and any medical claims made are FDA compliant. We help you create the necessary NDC codes required for structured product label submission.