Services

We’re in the business of assisting clients with their Blow Fill Seal programs. We provide a wide range of support and have the expertise needed to effectively take projects from initiation to completion.

Project / Program Management

 

Effective project management is as the heart of any successful endeavor in the pharmaceutical industry. Our project management practices are the game changer for our customers and we take pride in that.

The way me manage projects comes from a mix of traditional project management fundamentals, pharmaceutical industry best practices, and the lessons we’ve learned along the way. It all starts with a plan, which rolls into execution, and finishes with project closure activities. No matter the size or scope of the project, these three core activities are equally important and not one can be overlooked.

CDMO and Vendor Management

 

Having worked on both sides of the equation gives us a unique perspective on the key aspects of running a successful program between a pharmaceutical company and a manufacturing partner.

We support due diligence activities, audits, and contract development. Essentially, we act as a liaison throughout the entire relationship period between our client and the manufacturing partner.

Formulation and Process Development

 

If your formulation and process is not ready for the manufacturing floor, we have the depth and experience to take a bench procedure and modify it for the next step.

Technical Transfers

 

Tech transfers area sweet spot for Elemental Pharma. We support the whole scope of a tech transfer, from process transfer to labeling and packaging through validation.

Technology Evaluation

 

Evaluating blow fill seal as the basic sterile packaging platform is just one piece of the puzzle. Novel processes, formulation, automated visual inspection, CCIT, and packaging technology also become part of the mix. We assist our clients by first understanding their product and then evaluating the different options of pharmaceutical technology to be applied.

Submission Preparation

 

Whether it’s a new drug application, abbreviated submission, a postapproval change, or a medical device category, Elemental Pharma works can assist with the key stakeholders to ensure the submission content is whole.