Biological Regulatory Services
Biologicals are medicinal, therapeutic, diagnostic, and preventive products derived from living organisms. These include vaccines, serums, antigens, antitoxins, and other advanced formulations developed through biotechnology.
BlackBows provides end-to-end regulatory and compliance support for the manufacturing and import of biological products in India. Our approach is centered on precise documentation, regulatory accuracy, and strategic filings to ensure seamless approvals without delays or rejections.
For Manufacturer
- NOC for Form 29
- Test License
- Post Approval Changes
- Marketing Authorization
- Clinical Trial Permission (Phase 1, 2 & 3)
For Importers
- Registration
- Import License
- Marketing Authorization
- Clinical Trial Permission
FOR MANUFACTURERS
Manufacturing of biological products requires strict monitoring, quality control, and regulatory documentation. BlackBows supports manufacturers throughout the process—from NOC approvals to global clinical trials and post-approval compliance.
MARKETING AUTHORIZATION FROM CDSCO
Form 29
in India
(Phase 1, 2 & 3)
from SLA
Biologicals
From CDSCO
FOR IMPORTER
The import of biologicals requires strict regulatory compliance to ensure safety, efficacy, and availability. BlackBows provides complete support from registration to approvals and post-marketing compliance.
REGISTRATION PROCESS
(Phase I, II & III)
(ICMR Approval)
(Form 45)
Import License (Form 10)
(PMS / PSUR)
NOC for Form 29
NOC under Form 29 is required for manufacturing test batches of biological products for analysis and evaluation. This is a critical regulatory step that ensures compliance before proceeding to further approvals.
The process involves detailed documentation, including product information, manufacturing process, facility layout, equipment details, and technical qualifications of responsible personnel.
BlackBows provides structured and compliant support to secure NOC approvals efficiently. Our team ensures accurate documentation, thorough verification, and seamless submission—enabling clients to initiate testing and move forward in the regulatory process without delays.
Key Support Areas
- Documentation & Checklist Preparation
- Regulatory Filing & Compliance Review
- Coordination with Authorities
- End-to-End Approval Assistance