Regulatory Services for Generics - Overview
Generic and Innovator drugs bear many similarities, except the pricing. A Generic drug has the same dosage, safety, effectiveness, strength, stability, quality, and performance characteristics as an innovator drug. It is also consumed in a manner similar to an Innovator drug. However, it is far more economical when compared to an Innovator drug. With an objective to produce high quality pharmaceutical formulations, ANDA Pharmaceuticals and Generic drug manufacturers strive to identify the most critical needs of patients across the globe and devote their resources to meet them by developing safe, effective, and affordable healthcare solutions as an option to Innovator drugs.
Innovators are protected by patents and exclusivities, influencing how and when a generic drug can receive ANDA approval. These patents, usually issued by the US Patent and Trademark Office, protect the Innovator drug manufacturers by prohibiting others from selling generic versions of the same drug. Periods of marketing exclusivity for Innovator drugs can also impact the approval of generic drugs. Once these patents and marketing exclusivities expire or if they are successfully challenged by generic manufacturers, the ANDA submission process enables the approval and distribution of these generic drugs to the public.
Generic drugs are more cost-effective when compared to Innovator counterparts because they do not have to repeat animal and clinical (human) studies that were required by the Innovator. In addition, multiple applications for ANDA submissions for the same formula are often approved which creates competition in the marketplace that typically results in lower prices.
Generics Regulatory Expertise
Regulatory Services for Generics
- Prototype Formula Clearance for IIG (If required CC can be filed with FDA)
- Comprehensive support for Generic drug application submission and support in the Abbreviated New Drug Application (ANDA) Regulatory approval process.
- Quality by Design (QbD) Protocol & Report Review
- Final Formula Clearance with respect to IIG, dose proportionality, size, and shape
- Support in Finalization of API, excipients packing material specifications and test methods.
- Product Development Report Review
- Review Guidance in Stability Protocol, Hold Time Protocol, Process Validation Protocol and Master Formula Record
- Support in finalizing active pharmaceutical ingredients (API), excipients, packing material specifications, and test methods.
- All Method Validation and Verification/Transfer Reports
- Guidance on Bio study and Stability Study
- Guidance on Setting the Limits for Genotoxic and Elemental Impurities
- Support in preparing the CTA dossier.
- Regulatory support in CTA filing.
- Submission of Clinical Study Applications.
- CTA Regulatory submission.
- Filing the IND application.
- Offering CTA guidance.
Our Abbreviated New Drug Application (ANDA) services cover all aspects of the ANDA filing process, from ANDA submission requirements to the final stages of the ANDA Regulatory approval process.
We support the generic drug approval process, ensuring your products meet the necessary Regulatory standards.
We have expertise in pharmaceutical API, pharmaceutical ingredients and generic medicine registration spaces.
Our ANDA submission process includes detailed guidance on the ANDA filing procedure and the entire ANDA approval pathway, helping generic manufacturers gain swift Regulatory approval. We offer complete support for ANDA drug applications, ensuring compliance with the Global regulations.
