Raw Material & Intermediates

• Innovator Companies
• Generic Companies
• Biologics Companies
• Biosimilars Companies
• CRO (Clinical Research Organization)
• CDMO (Contract Development and Manufacturing Organization)
• CMO (Contract Manufacturing Organization)
• Raw Material & Intermediates
• API (Active Pharmaceutical Ingredients)
• Pharma Research & Development (R&D)
• Excipients
• Formulation (Drug/Biologics)
• Packaging Materials
• Medical Devices
• Analytical Labs
• OTC (Over the Counter)
• Cosmetics
• Nutraceutical
• Food/Dietary Supplement
• Veterinary

Pharmaceutical Raw Material and Intermediates

Raw Materials and Intermediates are essential components in the manufacturing of Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). Regulatory agencies such as the U.S. FDA (Food and Drug Administration), EMA (European Medicines Agency), ICH (International Council for Harmonisation), and WHO set strict guidelines to ensure their quality, safety, and compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).

Raw materials are the starting materials used in drug production. They can be active (APIs) or inactive (excipients, solvents, reagents, and catalysts). Regulatory agencies require manufacturers to conduct thorough quality testing, identity verification, and impurity profiling before using raw materials in drug manufacturing. Compliance with ICH Q7 (GMP for APIs) and ICH Q9 (Quality Risk Management) ensures proper control over raw material sourcing, testing, and storage.

Intermediates are partially processed substances formed during API synthesis. These compounds undergo multiple steps before becoming the final API. Regulatory authorities mandate in-process controls (IPC), stability studies, and validation of intermediate steps to ensure consistency and prevent contamination. Manufacturers must document intermediate data as part of Chemistry, Manufacturing, and Controls (CMC) requirements for regulatory submissions like Investigational New Drug (IND), New Drug Application (NDA), and Marketing Authorization Application (MAA).

Both raw materials and intermediates are subject to supplier qualification, change control procedures, and batch traceability to maintain regulatory compliance. Proper documentation and adherence to ICH, GMP, and pharmacopeial standards (USP, Ph. Eur., JP) ensure the integrity of pharmaceutical products from production to market.

Masuu provide specialized quality and compliance services to ensure that your raw materials and intermediates meet the highest regulatory standards. In pharmaceutical manufacturing, the quality of raw materials and intermediates directly impacts the safety, efficacy, and consistency of the final drug product. Our expert services help you maintain strict Good Manufacturing Practices (GMP) compliance and meet the requirements of regulatory authorities such as the FDA, EMA, ICH, and WHO.

Supplier Audits – We conduct on-site and remote audits of your raw material and intermediate suppliers to verify compliance with GMP, Good Distribution Practices (GDP), and regulatory guidelines. This helps ensure that all materials are sourced from reliable, qualified vendors.

Material Qualification – We assist in testing, analyzing, and validating raw materials and intermediates to ensure they meet pharmacopeial standards (USP, Ph. Eur., JP) and regulatory expectations. This includes identity testing, impurity profiling, and stability assessments.

Regulatory Documentation Support – We help prepare and manage essential regulatory documents, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), supplier qualification reports, and Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions such as IND, NDA, and MAA.