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Bachem AG

ChemWerth Inc

Rochem International Inc

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SWITZERLAND

UNITED STATES

Virtual BoothGeneric API development & supply// Non-infringement patent strategies development// Regulatory support.

Compliance & Regulatory Support

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- Service Details

Our Regulatory team provides compliance & regulatory support by managing documentation creation, review and submission while our Compliance group manages our Factory Compliance Programs, CMO management and facility inspections.

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: United States

Virtual BoothSpecializes in development of innovative, efficient manufacturing processes & reliable production of peptide-based APIs

Regulatory Documentation

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- Service Details

Bachem also has a strong regulatory background and we are well prepared to fully support you with the required regulatory documentation such as drug master files (DMFs)

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: United States

Virtual BoothGlobal leader in developing, sourcing and supplying pharmaceutical & animal health ingredients of Chinese origin

Expertise to File & Maintain DMFs/COS in USA

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- Service Details

Regulatory submissions filed by Rochem are prepared by our U.S. and Qingdao, China based Regulatory teams in coordination with product manufacturers. This ensures the most accurate and technically sound submission possible.

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: United States

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