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Bachem AG

CRMO Pharmmatecch

ChemWerth Inc

Rochem International Inc

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INDIA

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 BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and Oligonucleotides.

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

Virtual BoothProviding complete Pharmaceutical Outsourcing Solutions to Pharmaceutical Industry

Regulatory Support - US

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- Service Details

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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