Drugs and API Industry with RegaCats Solutions
The pharmaceutical and API industry faces stringent regulatory demands within India, presenting significant challenges for manufacturers and importers. Complex guidelines from the CDSCO and State Licensing Authorities (SLAs) often lead to delays, compliance errors, and substantial financial burdens. Staying abreast of evolving regulations and managing extensive documentation is a critical, yet often overwhelming, task. RegaCats Solutions addresses these challenges by offering specialized consultancy services for drug and API regulatory compliance. We provide comprehensive support for new drug applications, fixed-dose combination (FDC) registrations, clinical trial submissions, and all related regulatory procedures. Our expertise minimizes risks and ensures adherence to all applicable standards, allowing clients to concentrate on their core operations. To streamline your regulatory processes and secure timely approvals, contact RegaCats Solutions for a professional consultation.
Understanding Drugs and APIs
What is a Drug?
As defined by the Drugs and Cosmetics Act, 1940, a drug encompasses medicines for human and animal use, substances for disease diagnosis, treatment, or prevention, and insect repellents. These regulations are designed to ensure the safety and efficacy of all pharmaceutical products available in India.
What is a New Drug?
According to the New Drugs and Clinical Trials Rules, 2019, a new drug includes those not previously used in India, drugs with modified claims, fixed-dose combinations, modified-release formulations, and biological products. These classifications are essential for navigating the drug approval process.
What is a Subsequent New Drug?
A subsequent new drug refers to a new drug approved by the Central Licensing Authority, proposed for a new indication or indications, dosage, dosage form (including sustained release dosage form) and route of administration with in the time frame of 4 years of approval of new drug.
What is a Fixed-Dose Combination (FDC)?
Fixed-dose combinations involve products with multiple active ingredients for specific indications. These can include new drug combinations, new combinations of existing drugs, and modifications to existing combinations, each requiring specific regulatory approvals
Our Services
Our Comprehensive Regulatory Services
New Drug Application Support
We provide end-to-end support for new drug applications, ensuring all documentation and data meet CDSCO requirements. Our expertise streamlines the approval process, minimizing delays and maximizing efficiency.
Fixed-Dose Combination (FDC) Registration
We specialize in FDC registrations, handling the complexities of combining multiple active ingredients. Our team ensures compliance with all regulatory guidelines, facilitating timely approvals.
Clinical Trial Application Assistance
We assist with all aspects of clinical trial applications, from protocol development to regulatory submissions. Our expertise ensures compliance with ethical and regulatory standards, accelerating the trial process.
Active Pharmaceutical Ingredient (API) Regulatory Support
We offer comprehensive regulatory support for APIs, including DMF submissions and compliance with GMP standards. Our services ensure your APIs meet all regulatory requirements for market entry.
Import and Export Licensing
We manage the import and export licensing process for drugs and APIs, ensuring compliance with all customs and regulatory requirements. Our expertise simplifies international trade for your pharmaceutical products.
Manufacturing License Support
We assist with obtaining and maintaining manufacturing licenses, ensuring compliance with GMP and other regulatory standards. Our support helps you establish and maintain compliant manufacturing operations.
Ethics Committee Registration
We facilitate the registration of ethics committees, ensuring compliance with all relevant guidelines. Our services support ethical conduct in clinical trials and research activities.
Bioavailability/Bioequivale
nce Study Center Registration
We provide expert assistance in registering BA/BE study centers, ensuring compliance with regulatory requirements. Our support helps you establish and maintain compliant study facilities.
Test License
applications
We manage the application process for test licenses, enabling you to conduct necessary trials and analyses. Our expertise ensures compliance with all regulatory requirements for testing and analysis.
Importer’s Licence
applications
We manage the application process for importer’s licenses, making sure you can import your drugs and API’s into india legally and efficiently
Manufacturer’s Licence applications
We manage the application process for manufacturer’s licenses, ensuring your manufacturing process is compliant with all indian regulatory requirements.
Drugs and Cosmetics Act, 1940 form handling
We handle all necessary forms and paperwork required by the Drugs and Cosmetics act of 1940, to ensure your company is always compliant.
Regulatory Authorities Solutions
Why Choose RegaCats Solutions?
RegaCats Solutions offers unparalleled expertise in drug and API regulatory compliance. With over 15 years of experience, our team provides timely certifications, accurate documentation, and proactive solutions. We ensure your regulatory journey is smooth and efficient.
We specialize in new drug approvals, FDC registrations, clinical trial applications, and API regulatory support. Our expertise extends to import/export licensing, manufacturing compliance, and ethics committee registrations, providing comprehensive regulatory solutions.
What Our Clients Say
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