Formulation (Drug/Biologics)

• 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

Formulation refers to the process of designing and developing a drug product or biologic by combining an active pharmaceutical ingredient (API) or biologic substance with appropriate excipients to achieve the desired stability, efficacy, and safety. The formulation process is a critical stage in drug development, ensuring that the final product meets regulatory, quality, and therapeutic requirements.

1. Preformulation Studies & Regulatory Expectations

• Before finalizing formulation, preformulation studies are conducted to assess API stability, solubility, bioavailability, and compatibility with excipients.
• These studies follow regulatory guidelines such as ICH Q8 (Pharmaceutical Development) and ICH Q1A (Stability Testing of New Drug Substances and Products).

2. Formulation Development for Different Dosage Forms

• The choice of formulation depends on the intended route of administration (oral, injectable, topical, inhalation, etc.) and patient needs.
• Small-molecule drugs require precise control over disintegration, dissolution, and absorption properties, while biologics (e.g., monoclonal antibodies, vaccines, and cell therapies) require specialized formulation techniques such as lyophilization (freeze-drying), stabilization agents, and cold chain storage.

3. Regulatory Dossier & Quality Standards

• The formulation process must comply with Good Manufacturing Practices (GMP) and pharmacopeial standards.
• Regulatory submissions such as Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Biologics License Application (BLA) require detailed Chemistry, Manufacturing, and Controls (CMC) documentation on formulation composition, manufacturing process, and stability data.
• Biologic formulations must meet stringent guidelines under ICH Q5C (Stability Testing of Biotechnological/Biological Products) and FDA 21 CFR Part 610 (Biological Product Standards).

4. Stability & Compatibility Testing

• Formulations undergo stability testing under ICH Q1A guidelines to evaluate shelf-life, degradation pathways, and storage conditions.
• Container closure systems (vials, syringes, blister packs, etc.) must be evaluated for drug-excipient and drug-device compatibility.

A well-optimized formulation ensures product efficacy, patient safety, regulatory compliance, and commercial success. Proper regulatory planning and adherence to global quality standards are essential for a smooth approval process and market entry.

At Masuu, we offer comprehensive regulatory and quality support to help pharmaceutical and biotechnology companies navigate the complex process of drug and biologics formulation. Our expertise ensures that your formulations meet all regulatory, quality, and stability requirements, facilitating a smooth approval process and market entry.

1. Regulatory Submissions & Documentation

• We assist in the preparation and submission of Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Biologics License Application (BLA) filings.
• Our experts compile Chemistry, Manufacturing, and Controls (CMC) documentation, ensuring compliance with FDA, EMA, MHRA, PMDA, and WHO guidelines.
• We support dossier preparation in CTD/eCTD formats to meet global regulatory expectations.

2. Stability Studies & Formulation Optimization

• We conduct stability testing in accordance with ICH Q1A (Stability Testing of New Drug Substances and Products) and ICH Q5C (Stability Testing of Biotechnological/Biological Products) to determine shelf-life and storage conditions.
• Our team ensures compatibility between active pharmaceutical ingredients (APIs), excipients, and container closure systems to maintain product integrity and efficacy.

3. GMP Compliance & Quality Assurance

• We help implement Good Manufacturing Practice (GMP) and pharmacopeial compliance to ensure formulation quality and reproducibility.
• Our quality risk management strategies (ICH Q9) support robust formulation development, reducing regulatory challenges and ensuring approval success.

With Masuu’s expertise, you can develop high-quality, compliant formulations that meet regulatory standards, ensuring product safety, effectiveness, and successful commercialization.