Pharmaceutical R&D Materials

Key Pharmaceutical Manufacturing and Sourcing Topics

This document outlines key topics related to pharmaceutical manufacturing, regulatory documentation, and supply chain sourcing.

Regulatory and Quality Documentation

• DMF (Drug Master File)
• CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia)
• Written Confirmations
• GMP (Good Manufacturing Practice)
• Dossier

Product and Market Information

• FDF (Finished Dosage Form)
• Prices
• Patents
• Patents & Exclusivities
• News

Supply Chain Entities

• Manufacturer
• Licensing
• Distributer
• Suppliers

Analytical and Support Services Overview

The following is a structured list of pharmaceutical services, primarily focused on analytical testing and development.

Analytical Services

Analytical Method Development

• Biologic Drugs
• Capillary Electrophoresis
• Chiral HPLC & SFC Method Development
• Impurity Isolation and Identification
• Method Development and Validation
• Overview
• Preparative Resolution Processes
• Reference Substances / Qualification

Analytical Testing Services

• Adhesive Strength
• Amino Acid Analysis
• Batch Release and Stability Lot Testing
• BET Surface Area
• Bulk and Tapped Density
• Capillary Electrophoresis
• Chromatography (TLC / LC / HPLC / UPLC / GC)
• Complete Pharmacopoeial / Compendial Testing
• Content Uniformity / Homogeneity
• Disintegration
• Dissolution
• DSC
• Friability
• FTIR / NIR
• Gas Testing
• Hardness
• High Potency APIs (HPAPIs)
• Hot-Stage Optical Microscopy
• Impurity Isolation and Identification
• Inhalation Products
• Isoelectric Focusing
• Karl Fischer / Water Analysis
• LC - MS - MS
• Light Microscopy
• MALDI-TOF Mass Spectrometry
• Mass Spectrometry and GC / MS
• Mass Spectrometry and LC / MS
• Microbiology
• Moisture Sorption
• Native Gel Electrophoresis
• Osmotic Strength / Osmometer
• Overview
• Particle Size
• Particulate Matter
• Pharmaceutical Water
• Physical Characterization
• pKa and LogP
• Potentiometry
• Raman
• Residual Solvents
• SEM
• Solid State Characterization
• Solid State NMR
• Solution NMR-Carbon
• Solution NMR-proton
• Sorption and Desorption
• Structure Elucidation
• TGA
• Trace / Elemental / Heavy Metals
• UV Spectrophotometry
• XRPD

BioAnalytical Services

• Bioanalytical & Biomarker Testing Services
• Bioequivalence / Clinical / Pre-Clinical Testing
• Calculation and Modeling of Pharmacokinetic Parameters
• Capillary Electrophoresis
• Immunoassay & Cell Based Assay
• Method Development and Validation
• Overview
• Protein Isolation, Identification and Characterization
• Proteomics
• Quantitative Bioanalysis
• Structural Characterization

Biologic Drugs

• Biopharmaceuticals

Container Closure Integrity

• Airborne Ultrasound / Seal-Scan
• Assessment Programs
• Electrical Conductivity / High Voltage Leak Detection (HVLD)

Container Qualification

• Pharmaceutical Glass
• Container Performance
• Testing Services

Extractables and Leachables

• Chemical Characterization
• Impurities
• Impurity Isolation and Identification
• Testing Services
• Toxicological Risk Assessment (TRA)

Packaging and Distribution Testing