ANDA Submission Consultant Services

ANDA Submission Consultant ServicesBefore your product can be finalized, first, you must submit the concept of your new product to the FDA. The ANDA submission form can be extensive and very detail-oriented. If your product doesn’t align with this submission, then it can derail your project and cause costly mistakes. Whether you’re using our product development services or need consulting services for ANDA submission outsourced, PD Partners provides the assistance you need to avoid submission obstacles and get your product approved without a hitch.

Our ANDA submission consultant services walk you through the submission process, identifying pain points that may need to be addressed before filing and ensuring that your project deliveries align with the parameters of your submission. In some cases, you may discover during this step of the process that we need to re-evaluate some decisions initially made, and substitute some aspects of your project as amendments later on in the project. This is normal and will help you get approved quicker.

How It Works

From discovery to finalizing your product, PD Partners is with you every step of the process. That includes helping you file properly with government regulatory services such as the ANDA. With years of experience helping file FDA approval documents, we know how to identify the common pitfalls — such as:

  • Parameters not matching
  • Ingredient inconsistencies
  • Missing information
  • Additional required paperwork

Our Proven Process

  1. Analysis and discovery
  2. Testing
  3. Establishing a sample formula
  4. Scaling capabilities
  5. Modification and adjustments
  6. Labeling and parameter testing
  7. Finalizing the product

Benefits of Working with PD Partners

  • Avoid common filing mistakes for quicker approvals
  • Satisfy FDA and ANDA requirements
  • Streamline the product development process
  • Eliminate the risk of additional filing fees

The PD Partners Guarantee

Our testing, storage, and stability facilities provide the work you need cost-effectively and professionally. With 15,000 square feet of space, our facilities are pre-approved by the FDA and are licensed as a Class 1 by the DEA — making us one of only 30 locations in the US to provide cannabinoid-containing product testing.

Our commitment to doing right by both you and ourselves ensures that we’ll never cut corners to make your product work. From keeping our facilities compliant with government regulations to helping you get your new product approved, we’re here to help you navigate the complexities of the new product development process.

Serving Your Industry

Biopharmaceuticals Consumer Health & Nutrition