At Biomaxgen, we are dedicated to guiding aspiring pharmaceutical entrepreneurs through the intricate process of establishing successful pharmaceutical companies in India. Our comprehensive consultancy services encompass every critical aspect of pharmaceutical company formation, ensuring our clients navigate the regulatory landscape with confidence and precision.

Our Mission

Our mission is to empower pharmaceutical ventures by providing expert guidance and support in obtaining essential licenses and certifications, facilitating compliance with India's stringent regulatory standards. We strive to be the trusted partner for businesses aiming to make a significant impact in the healthcare sector.

Our Services

1. Drugs Manufacturing License

   Securing a Drugs Manufacturing License is a fundamental step in establishing a pharmaceutical manufacturing unit. This license authorizes the production of drugs intended for sale or distribution. We assist clients in preparing and submitting the necessary documentation, ensuring compliance with the Drugs and Cosmetics Act, 1940, and its accompanying rules. Our team liaises with the Central Drugs Standard Control Organization (CDSCO) and State Licensing Authorities to facilitate a seamless approval process.

2. Test License on Form 29

   Before commencing commercial production, it's imperative to conduct thorough examination, testing, and analysis of pharmaceutical products. A Test License, issued in Form 29, permits the manufacture of drugs exclusively for these purposes. We guide clients through the application process, which involves submitting Form 30 to the State Licensing Authority, ensuring all prerequisites are meticulously met. This license is crucial for maintaining quality assurance and compliance with regulatory standards.

   cdsco.gov.in

3. Loan License for Drugs Manufacturing

   For entities that prefer to outsource manufacturing while retaining their brand identity, obtaining a Loan License is an optimal solution. This license allows a company to utilize the manufacturing facilities of another licensee. We assist in the preparation and submission of Form 24A, along with the requisite documents, to the appropriate authorities. Our experts ensure that all contractual agreements and compliance measures are in place, facilitating a smooth operational workflow.

   drugscontrol.tn.gov.in

4. Regulatory Compliance and Quality Assurance

   Navigating the complex regulatory environment of the pharmaceutical industry requires meticulous attention to detail. We provide comprehensive support in adhering to Good Manufacturing Practices (GMP) as outlined in Schedule M of the Drugs and Cosmetics Rules, 1945. Our services include assistance with facility design, process validation, documentation, and staff training, ensuring that all operations meet the highest standards of quality and compliance.