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Recent 505b2 Nda Inquiries

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505b2 For Drugs

We require an expert to assist with 505b2 for a drug/device combination. We are repurposing an existing inhalation device coupled with a medical gas for home use. We plan to submit to the fda within 3-4 months and need help asap. We are looking for remote collaboration, thus location is of no importance. 505b2 has to be your core expertise. Referrals are also welcomed, thank you.

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    Us Cmc Sections For Nda

    We are a bio-technology firm who is looking for a writer for a cmc section of nda. The individual must have experience writing a cmc section, and will be conducting additional research for us. The ideal expert will be in the tampa area, but we are also open to working with individuals based on the east coast. We are not open to working with individuals based outside of the us.

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      Jukka |President, Director

      We are a US and Canadian based CRO and can provide you all services needed. Our HQ is in Georgia. P...

      1.3 Hours Later
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      Timothy |Principal

      I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Qualit...

      1.4 Hours Later
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      Rajesh |Zintro Expert

      CMC expert section 2 for drug substance and section 3 for drug products available on hourly basis w...

      1.4 Hours Later
    +18 Other Responses
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    Anda And Nda Drug Product Development

    We plan to launch a natural/organic lice prevention spray for kids, and we wonder if such product falls under nda or anda. In case it is not, which we believe is the case, at least we need some advising about how soft or hard can be our claims and copy on packaging. Thanks and best regards. Marios

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