We contribute your productivity increase by our outsourcing services !
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- Hearing from the client about the product (New Drug,Generic,Rx,OTC,API,Dosage form,Previous examples,etc.) to the possible extent
- Discussion about the possibilities to the next step
- Exchange Non-Disclosure-Agreement (NDA), if necessary
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Initial Consultation (Free)
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- Hearing about current product license situation, formulation, specification, etc. under NDA.
- Discussion and judgement whether moving on to the next step.
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Documents/Data Check |
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Review the documents, data, etc. for the preparation of ASEAN CTD.
- After agreeing on schedule, fee, mutual responsibilities, etc., ACTD preparation starts based on service agreement.
- Fee will be charged from this step.
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ACTD Preparation Start |
- Prepare ACTD based on the provided documents, data, information, etc.
- Start the additional experiments, if necessary.
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ACTD Preparation |
- Prepare ACTD collaborating with client.
- Face to face meeting may be necessary even though it is not regularly.
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ACTD Amendment |
- Submit ACTD to client.
- Modification, amendment will be made, if necessary.
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ACTD Completion Application |
- Submit ACTD from client to applicant.
- Client/Applicant communication is very important
- Applicant submit to the authority.
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Inquiry & Submission |
- Collaborate with client/applicant on inquiries from the authority.
- Prepare answer letter and submit it from the applicant within designated period of time.
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Approval & Registration |
