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Anlaytical Testing

Analytical Method Development Bioanalytical Testing Container Closure Integrity Testing Container Testing

Helium Leak Testing High Voltage Leak Detection

Extractables and Leachables Testing Full Analytical Testing Impurity Testing Method Validation Microbiological Testing

Bacterial Endotoxin Test Sterility Test

Nitrosamine Testing Raw Material Testing Reference Standard Qualification Stability Studies

Clinical Studies

ADME PK Drug Metabolism Forced Degradation Studies IND Enabling Studies Metabolite Profiling

Drug Development

API Process Development Bioconjugates

Antibody-Drug Conjugates (ADCs) Antibody-Oligonucleotide Conjugates (AOCs) Biconjugate Design Linker Payload Radionuclide Drug Conjugates (RDCs)

Antibody Design Antibody Development Antibody Discovery Biosimilars

Monoclonal Antibodies Recombinant Insulins

Cell Banking Cell Line Development Clone Screening Mammalian Cell Culture Recombinant Proteins

Cell & Gene Therapy Custom Synthesis Drug Product Development

Formulation Development Pre-formulation Studies Process Development and Scale-up Regulatory Support

Drug-Drug Interactions Immunogenicity Assays Quality By Design (QBD) Technology Transfer Vendor Qualification

Drug Discovery

Animal Studies Assay Biology Candidate Selection (IND) Custom Assay Development High-throughput Screening (HTS) Hit to Lead Categorization Lead Optimization Lipidomics Medicinal Chemistry Structure Activity Relationship Studies (SAR) Synthesis of Compound Libraries Target to Lead Generation

Manufacturing

API Intermediates

Advanced Intermediates Early-Stage Intermediates

APIs (Drug Substances)

Generic APIs Highly potent APIs (HPAPIs) Jet Milling mRNA Production Peptides Radiolabeled APIs Small Molecules

cGMP Manufacturing Vaccines

Finished Drug Products

Creams Gels Injectables Lotions Oral Liquids (Syrups, Suspensions, Drops) Oral Solids (Tablets, Capsules)

Sterile Manufacturing

Aseptic Processing Lyophilization (freeze-drying) Terminal Sterilization

Packaging

Ampoules Filling Blister Packing Blow-Fill-Seal (BFS) Bottle Filling Cold Chain Custom Kitting IV Bags Prefilled Syringes Primary Packaging

Repackaging & Rework Secondary Packaging

Tube Filling Vapor & Spray Inhalers Vial Filling Vial/Ampule Labeling

Regulatory & Compliance

ANVISA (Brazil)

cGMP (3rd Party)

EDQM (Council of Europe)

EMA (European Union)

FDA (USA)

GMP (3rd Party)

HSA (Singapore)

ISO 9001

MFDS (South Korea)

MHRA (UK)

NMPA (China)

PMDA (Japan)

TGA (Australia)

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Argentina

Australia

Belgium

Brazil

Canada

Chile

China

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Germany

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Mexico

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South Korea

Spain

Switzerland

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Thailand

U.S.A.

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CRO companies by country

CRO Services in Argentina CRO Services in South Korea CRO Services in India CRO Services in Chile CRO Services in U.S.A. CRO Services in France

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