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    Looking for United States? Find Sales, Marketing, Registration for Regulatory Affairs / Pharmacovigilance & other pharma service details on PharmaCompass.

    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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    01 ChemWerth Inc (1)

    02 Rochem International Inc (1)

    03 CRMO Pharmmatecch (1)

    04 Catalent Pharma Solutions (1)

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    01 India (1)

    02 U.S.A (3)

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    ChemWerth Inc

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    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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    COMPLIANCE & REGULATORY SUPPORT

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    ChemWerth's regulatory team provides compliance & regulatory support by managing documentation creation, review and submission while its compliance team manages factory compliance programs, CMO management and facility inspections, etc.

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    Pharma Service: Sales, Marketing, Registration

    Category: Regulatory Affairs / Pharmacovigilance

    Sub Category: United States

    ChemWerth Compliance & Regulatory Support

    CPhI Worldwide 2023

    Booth # 6J40

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    Rochem International Inc

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    • FDA
    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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    EXPERTISE TO FILE & MAINTAIN DMF/COS IN USA

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    Rochem’s regulatory group files & maintains Drug Master Files (DMF) and Certificates of Suitability (COS) in all regulated markets, such as the US, China, etc.

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    Pharma Service: Sales, Marketing, Registration

    Category: Regulatory Affairs / Pharmacovigilance

    Sub Category: United States

    Expertise to File & Maintain DMF/COS in USA

    CPhI Worldwide 2023

    Booth # 7K19

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    CRMO Pharmmatecch

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      Virtual Booth Upload your Marketing & Sales content on your company Virtual Booth, click HERE
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      REGULATORY SUPPORT - US

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      CRMO can assist your company with FDA pre and post approval inspections, regulatory interpretation & submissions such as DMFs to the US FDA & EU Community, Dossiers for Certificate of Suitability of monographs of the European Pharmacopoeia, etc

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      Pharma Service: Sales, Marketing, Registration

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      Catalent Pharma Solutions

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      REGULATORY SUPPORT SERVICES

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      Catalent offers customized regulatory affairs services for global markets and supports the full product lifecycle for products contract manufactured at Catalent. The regulatory submission CMC writing includes IND, CTA, NDA, MAA, NDS, ANDA, BLA, DMF, etc.

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      Pharma Service: Sales, Marketing, Registration

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