Excipients

• 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

Pharma Excipients

Pharma Excipients

Excipients are pharmacologically inactive substances used in drug formulations to support manufacturing, stability, bioavailability, safety, and the delivery of the Active Pharmaceutical Ingredient (API). Although they do not exert therapeutic effects, excipients play a crucial functional role in drug products by influencing dosage form performance, stability, patient acceptability, and overall drug quality. Regulatory authorities such as the U.S. FDA, EMA, MHRA, PMDA, and WHO mandate compliance with Good Manufacturing Practices (GMP), pharmacopeial standards (USP, Ph. Eur., JP), and ICH guidelines, including Q3C for residual solvents, Q3D for elemental impurities, Q9 for risk management, and Q10 for quality systems.

Regulatory Considerations for Excipients
Quality & Safety Standards – Excipients must comply with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and pharmacopeial standards.
Regulatory Documentation – Excipients require detailed safety assessments, stability studies, and impurity profiling as part of Chemistry, Manufacturing, and Controls (CMC) documentation in drug regulatory submissions like IND, NDA, ANDA, and MAA.
Excipient Regulatory Filings – Manufacturers submit Drug Master Files (DMFs), Certificate of Suitability (CEP), or Active Substance Master Files (ASMFs) to regulatory agencies for excipient approval and qualification.
Risk Assessment & Toxicity Evaluation – Excipients must undergo toxicological studies, compatibility testing, and risk assessment in accordance with ICH Q3C (Residual Solvents), ICH Q6A (Specifications for New Drug Substances and Products), and ICH Q9 (Quality Risk Management).

Proper regulatory compliance ensures that excipients meet global quality and safety standards, minimizing risks and supporting successful drug formulation, approval, and commercialization.

Masuu provide specialized regulatory and quality services to ensure that your excipients comply with global standards and contribute to the safety, stability, and efficacy of your pharmaceutical products. Excipients play a crucial role in drug formulations, and their quality, consistency, and regulatory compliance are essential for successful drug development and approval.

Our Key Services:

1. Supplier Qualification & Compliance Audits

• We assess and qualify excipient suppliers to ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and pharmacopeial standards.
• Our supplier audits help verify raw material sourcing, quality control measures, and risk mitigation strategies to prevent contamination or variability.

2. Risk Assessment & Toxicological Evaluation

• We conduct detailed risk assessments, impurity profiling, and toxicology evaluations in accordance with ICH Q3C (Residual Solvents), ICH Q6A (Specifications), and ICH Q9 (Quality Risk Management).
• Our experts ensure excipients are safe, compatible with active pharmaceutical ingredients (APIs), and suitable for intended formulations.

3. Regulatory Documentation & Dossier Preparation

• We assist with the preparation and submission of Drug Master Files (DMFs), Active Substance Master Files (ASMFs), and Certificates of Suitability (CEPs) to regulatory authorities such as the FDA, EMA, and PMDA.
• Our team ensures excipient data meets all regulatory requirements for inclusion in CTD/eCTD submissions for IND, NDA, ANDA, and MAA applications.

With Masuu’s expertise, you can ensure that your excipients meet global regulatory standards, maintain product quality, and support a successful drug approval process.