Generic Companies

• 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

Regulatory Support for Generic Pharma Companies

Masuu Global recognizes the essential role that generic pharmaceutical companies play in providing affordable access to life-saving medications. These companies are responsible for manufacturing and distributing medications that are bioequivalent to brand-name drugs, once the original patents expire. By doing so, they ensure that essential medications are accessible to a broader population at a much lower cost, improving public health and providing sustainable solutions.

Unlike innovator companies, which focus on the research and development of new drugs, generic pharmaceutical companies focus on replicating existing medications with the same active ingredients, dosage forms, and efficacy as the branded versions. This process requires adherence to rigorous regulatory approval procedures to ensure that the generics meet the same quality, safety, and efficacy standards.

At Masuu Global, we provide end-to-end regulatory support to generic pharmaceutical companies, ensuring a smooth journey from dossier preparation to market approval. Our team of regulatory experts is committed to ensuring timely submissions and approvals, helping you maintain a competitive edge in the global market.

1. Dossier Preparation
   • We assist with the preparation of Regulatory Dossiers for generic products, including CTD (Common Technical Document) submissions, ensuring they meet the required standards for market approval.
2. Regulatory Submission Management
   • Our team expertly manages the submission process to regulatory agencies such as the FDA, EMA, and WHO, ensuring compliance and accelerating time-to-market.
3. Bioequivalence Studies
   • We guide you through the requirements for bioequivalence studies, ensuring that your generic products meet the necessary standards to be considered bioequivalent to their branded counterparts.
4. Labeling and Artwork
   • Masuu Global helps you create and review labeling and packaging artwork that aligns with the regulatory guidelines of different markets, ensuring compliance and clarity.
5. Market Authorization
   • We manage the process of obtaining market authorization for your generic drugs, working with regulatory authorities to ensure a smooth and timely approval.
6. Regulatory Advisory
   • Our regulatory experts provide ongoing guidance on regulatory requirements, market trends, and compliance challenges, helping you navigate the complexities of global markets.
7. Post-Approval Support
   • After your generic product is approved, we offer post-market surveillance and adverse event reporting, ensuring continued compliance and market safety.

• Timely Submissions
• Regulatory Expertise & Global Expertise
• Cost-Effective Solutions
• End-to-End Support
• Global Market Access
• Commitment to Excellence
• Dedicated Support