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

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01 ChemWerth Inc (1)

02 Rochem International Inc (1)

03 Catalent Pharma Solutions (1)

04 CRMO Pharmmatecch (1)

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01 India (1)

02 U.S.A (3)

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ChemWerth Inc

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Generic API development & supply// Non-infringement patent strategies development// 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 2022

Booth # 110A10

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Rochem International Inc

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Global leader in developing, sourcing and supplying pharmaceutical & animal health ingredients of Chinese origin.

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EXPERTISE TO FILE & MAINTAIN DMFS/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 DMFs/COS in USA

CPhI Worldwide 2022

Booth # 120D72

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Catalent Pharma Solutions

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More products, better treatments, reliably supplied.

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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

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: United States

Regulatory Support Services

CPhI Worldwide 2022

Booth # 90G20

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CRMO Pharmmatecch

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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

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: United States

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