Whether you are a large pharmaceutical company that needs to outsource a single regulatory submission, a small or virtual biotech company with limited regulatory affairs resources, or a company with a submission that does not seem to fit into a regulatory box.

Ashuren can help!

Our qualified and experienced regulatory affairs personnel can provide you with timely advice on the following:

• Strategies, submissions and regulatory agency interactions
• International requirements
• Quality, Safety and Efficacy issues
• Dossier/submission preparation or review
• Expert regulatory CMC compliance advice throughout development
• Liaising with regulatory agencies and facilitating regulatory agency meetings

Ashuren health sciences can assist your company with its regulatory affairs objectives in the following product areas:

• Pharmaceuticals and Biotechnologicals
• Biologics
• Medical Devices
• Cosmetics and Personal Care Product
• NHPs
• Veterinary products
• Radiopharmaceuticals
• Generics