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Biosimilars Links

Why Consider Goodwin Biotechnology?
Process Development and cGMP Manufacturing Strategy
Characterization and Comparability Studies
Regulatory Strategies

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Consider us counselors and advisers, but most important, our clients call us partners

Whether you’re ready to select a CMO or just thinking about it, talk to us. We’ll review your requirements then share our expertise and experience to design the appropriate manufacturing, analytical and regulatory strategies. Our focus is on being your strategic partner who will design a plan that: 

• Produces the highest quality material
• Is time and operationally efficient
• Is cost effective

For more information on Biosimilars, please fill out the form above... thanks!

Biosimilars Regulatory
Strategy

We will work with you and the relevant regulatory group(s) to develop a strategy to identify regulatory pathways and gain regulatory approval of your Biosimilar in accordance with the requirements of the FDA, EMEA, WHO, DCGI, and / or others.

For more information on the following guidelines, on the link below:
FDA Guidelines
EMEA
WHO
The Drugs Control General of India (DCGI)
China's FDA

Based on the challenges of a Biosimilar, it is critical to have pre-submission meetings with the relevant agency or agencies to discuss the approach, then maintain open communications for frequent consultation throughout the development process.

For more information on our Biosimilars services please fill out the form below.

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