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To provide helpful and useful solutions to the pharmaceutical industry in the areas of Regulatory Affairs, Quality Assurance, Science & Technology and Packaging.
Contact Us
| We are located in Stanhope, NJ. |
| Phone: |
973- 691-2249 |
| Fax: |
973-691-3070 |
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| [A]NDA |
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Entire application , from review to eCTD |
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Prepare eCTD only |
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Review and/or
compile
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CMC section only |
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Monitor bioequivalence studies |
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Prepare Annual Reports, including PSUR's |
| Labeling |
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Review data, compile and format for filing. Scan and prepare your eCTD |
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Draft labeling for container, blisters, cartons & package insert |
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Side by side comparisons |
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SPL labeling |
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