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| International Regulatory Affairs Services Inc. |
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| We offer a complete range of regulatory services for medicinal and other healthcare-related products, and can assist your team with all aspects of Regulatory Affairs/Compliance, Clinical and Product Development. We collaborate with an extensive network of professionals in the US and overseas to better serve our clients from product discovery to commercialization. We use our experience and expertise, our diligence, and our commitment to quality to ensure that our clients meet their regulatory needs and goals. Contact us to discuss your project and/or obtain an estimate. |
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| Areas of focus: |
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- Preparation and submission of Common Technical Document (CTD) for marketing applications in Europe and US
- Preparation and submission of clinical trials in Europe (new CTA process) and US (IND process)
- Regulatory Strategy for Drug Development in Europe
- Preparation of meeting with the EMEA for scientific advice and/or pre-submission
- Liaison with Regulatory Authorities (National European Member State, EMEA, FDA)
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- Set-up of Quality Systems (Good Research Practice, Good Laboratory Practice, and Good Manufacturing Practice)
- Preparation of SOPs, policies, and batch records
- Preparation of customized notebooks
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- Hot Topics Workshops Series
- Analytical Methods Validation
- Customized training
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International Regulatory Affairs Services Inc.
10626 Wagon Box Way, Highlands Ranch, CO 80130
Phone: (303) 683-3512  Fax: (303) 683-3512
E-mail: catherine_bernard@earthlink.net
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