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Here are some requirements needed to start the process…
About Us
acg|consultancy Since 2017
We simplify the process and the acquisition of permits, licenses, and certification. Below are the set of requirements.
FDA CPR
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Notarized Application Form: Fill out the FDA application form, which is often specific to the type of product being registered, and have it notarized.
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Proof of Local Agent: Provide documentation that confirms the appointment of a local agent who will represent your company before the FDA.
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Product Labeling: Submit the proposed labeling for your product, which should comply with FDA regulations and include essential information about the product.
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Product Specifications: Provide detailed specifications and technical information about the product, including its composition, formulation, and manufacturing process.
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Product Testing Data: If required, include test results and data to demonstrate the safety and efficacy of the product.
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GMP Certification: For some products, you may need to provide proof of Good Manufacturing Practices (GMP) compliance.
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Certificate of Analysis (CoA): Include a Certificate of Analysis for the product, which verifies its quality and composition.
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Letter of Undertaking: Submit a letter of undertaking that commits to complying with FDA regulations and post-registration requirements.
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Fees: Pay the appropriate registration and processing fees as required by the FDA.
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Other Supporting Documents: Depending on the specific product, additional documents or information may be necessary to demonstrate compliance with FDA regulations.
FDA CPN
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Notarized Application Form: Fill out the FDA application form for product notification and have it notarized.
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Proof of Local Agent: Provide documentation to confirm the appointment of a local agent who will represent your company before the FDA.
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Product Labeling: Submit the proposed labeling for your product, which should comply with FDA regulations and include essential information about the product.
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Product Specifications: Provide detailed specifications and technical information about the product, including its composition, formulation, and manufacturing process.
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Fees: Pay the appropriate notification and processing fees as required by the FDA.
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Product Testing Data (if applicable): Depending on the product type, you may need to provide test results and data to demonstrate its safety.
Please note that these are general requirements, and the agency may have additional requirements or specific guidelines for different permits, licenses, certifications categories. Additionally, working with acg|consultancy can be highly beneficial in navigating the process – simplified and hastle-free
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San Francisco, CA 94143
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(02) 8716 9487
(+63) 967 293 3055