MLC, LLC Consultant
Groton, MA 01450 Phone: 978.448.0953Email: kelsey@mccormicklifescience.com
What We Do > Products
Having template headaches? Looking for consistent, easy-to-use templates for your internal documents and Regulatory submissions? Are you contracting studies? Would you like the ease of providing your CRO's with templates to maintain your "company look" and consistency?
If you would like to see samples or have any questions about our products, please contact us directly.
Available Templates Include:
CTD Submission Component Templates (for INDs and NDAs): 103 Word Documents in either Word 2003 or 2007 (compliant with ICH guidelines)
Clinical Study Protocol: compliant with ICH guidelines
Investigator Brochure: compliant with ICH guidelines
Clinical Study Report: compliant with ICH guidelines
Pre-IND/Pre-NDA Meeting Request: compliant with 21 CFR 312.82/312.4
Pre-IND/Pre-NDA Meeting Package: compliant with 21 CFR 312.82/312.4
Annual Reports: compliant with 21CFR312.33
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*Included with all templates:
- Pre-defined headers, titles, headings, and “hidden” support text (directly from the guidelines/regulations) to assist authors and reviewers (support text can be removed if requested)
- Instructions and Tips document to detail out any helpful user instructions and quick formatting edits that can be made using the templates
- Product customization (Header and footer information will be updated to the client’s request to include their information mutually agreed upon); additional customization will require further considerations/discussions
* Do not see what you are looking for? Please give us a call and we will work to meet your specific needs!
Interested in collaborating with us or have questions?
Please send us a message
Bridging the gap between discovery and market with efficient execution of the approval process
