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Single-Entity Combination Products

Single-Entity Combination Products Teaser

Meeting regulatory and end-user needs, one solution at a time

Today, there’s no doubting that we’re in the midst of unprecedented innovation in pharma-biotech and medical devices. 

Keeping up with regulatory demands in these industries can be daunting. But, what no one talks about are the exponential challenges that arise in the wake of combination product development and marketing. 

Not only are you developing combination products that deliver safe, effective results for patients; but, in many cases, your product must be end-user friendly—foolproof, even. 

Whether you’re a drug developer who’s been thrown into the medical device arena, or you’re a medical device maven who’s uncertain how to tackle the ins and outs of pharmaceutical regulation, Azzur Group is ready to take on your challenges. 

Anticipating the Challenges

From clinical trials to full-scale commissioning to change control, Azzur’s certified cGMP consultants are armed with hundreds of years of experience across the life science spectrum. 

Backed by a nationwide network of consulting, validation, lab, and IT compliance experts, Azzur Group is able to provide a holistic solution to the industry’s most demanding challenges and regulatory demands. 

What does that mean for you? Based on your core competency, we’ll put into action a robust team to help you start, scale, and sustain your GxP manufacturing.

Solutions for Combination Product Manufacturers

Project Management
Instead of juggling suppliers, development, design, and testing, we’ll take the wheel and manage communication and deadlines. That way, you can continue doing what you do best.
Training
Our full-scale, customizable training services encompass in-person kinesthetic training, as well as online modules, that can be used to bring your entire workforce up to speed and guarantee a validated state for your cGMP organization from installation through operation and performance.
GxP Advisory and Consulting
Our nationwide network of Azzurians faces your drug development hurdles head-on. We’ll work alongside your team and/or suppliers to remedy potential issues with manufacturing, commissioning, and process validation, as well as GxP quality control and compliance.

Interested in Learning more?