Regulatory Document Archive

FDA and ICH Regulatory Documents are here for your convenience

We use a variety of regulatory documents published by the United States Food and Drug Administration and the International Conference on Harmonization (ICH) to guide you in decision making about your product.  We want these documents to be available to our clients all in one easy to navigate place so we have gathered a collection of the most important documents hear on our website for your convenience.  We want you to reference these documents any time and to feel free to ask us any questions about the implications of these regulatory guidelines for your development plan.

Regulatory Documents for the Development of Products for the Treatment of Cancer and other Life Threatening illnesses

ICH S9 Step 4 Guideline for Oncology Products

Regulatory Documents for the Development of Products for Non-Life Threatening Illnesses

ICH M3 R2 Guideline Non-Life Threatening Conditions

ICH S5 R2 Guideline Reproductive Safety

ICH S8 Guideline Immunology

ICH S10 Step 4 Guideline Photosafety