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France

Virtual Booth

Skyepharma has a track record of supporting regulatory approvals for oral dosage forms in the US, Europe, etc. It ensures registration & post-approval strategies, regulatory agency inquiries & inspections with life cycle management support.

REGULATORY SERVICES

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: France

Biopharm America 2022

Attending

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

ChemWerth Inc

U.S.A

Virtual Booth

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.

COMPLIANCE & REGULATORY SUPPORT

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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

We globally supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

Transo-Pharm Handels GmbH

Germany

Virtual Booth

Transo-Pharm offers scientific and regulatory services to the pharmaceutical industry and their suppliers dealing in APIs and finished drugs (human and veterinary). It provides GMP, audit & inspection and other regulatory (eCTD) support.

SCIENTIFIC & REGULATORY SERVICES

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Sub Category: Germany

Transo-Pharm Handels Scientific & Regulatory Services

CPhI Worldwide 2022

Booth # 110D20

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

Rochem International Inc

U.S.A

Virtual Booth

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.

EXPERTISE TO FILE & MAINTAIN DMFS/COS IN USA

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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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Neuraxpharm

Spain

Virtual Booth

Lesvi offers the complete range of Neuraxpharm’s FDF products (quality generics, pharmaceuticals and nutraceuticals) including access to our regulatory dossiers.

REGULATORY DOSSIERS

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Category: Regulatory Affairs / Pharmacovigilance

Sub Category: Spain

DDF Summit 2022 US

Not Confirmed

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Inke S.A

Neuraxpharm's APIs manufacturing plant.

Spain

Virtual Booth

Inke provides full technical and regulatory support to customers including preparation of Drug Master Files for USA, Europe, Japan and Korea, preparation of CEPs (Certificates of Suitability of Monographs of the EP), and e-CTD electronic management.

REGULATORY SERVICES

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: Spain

CPhI Worldwide 2022

Booth # 110B02

More products, better treatments, reliably supplied.

Catalent Pharma Solutions

U.S.A

Virtual Booth

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.

REGULATORY SUPPORT SERVICES

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: United States

CPhI Worldwide 2022

Booth # 90G20

We globally supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

Transo-Pharm Handels GmbH

Germany

Virtual Booth

Kemimac S PTE LTD (Singapore) offers scientific and regulatory services to the pharmaceutical industry and their suppliers dealing in APIs and finished drugs (human and veterinary). It provides GMP, audit & inspection and other regulatory (eCTD) support.

SCIENTIFIC & REGULATORY SUPPORT

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Pharma Service: Sales, Marketing, Registration

Category: Regulatory Affairs / Pharmacovigilance

Sub Category: Singapore

Transo-Pharm Handels Scientific & Regulatory Support

CPhI Worldwide 2022

Booth # 110D20

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

Rochem International Inc

U.S.A

Virtual Booth