ASTER APPROVALS LEADING TO ENHANCED ACCESS TO MARKETS !
Human blood is covered under the definition of a ‘Drug’ under the Drugs & Cosmetics Act. Hence requirements for collection, storage, processing and distribution of whole human blood, human blood components by blood banks and manufacture of Blood Products are highly regulated in India. “Blood” is defined to include whole human blood, drawn from a donor and mixed with an anti-coagulant; a “Blood Bank” is defined as a place or organization or unit or institution for carrying out all or any of the operations for collection, apheresis, storage, processing and distribution of blood drawn from donors and/or for preparation, storage and distribution of blood components; a “Blood Component” means a drug prepared, obtained, derived or separated from a unit of blood drawn from a donor; and a “Blood Product” is defined as a drug manufactured or obtained from pooled plasma of blood by fractionation, drawn from donors.
In brief, there is a set procedure of application submission, product testing, registration dossier submission, review and approvals from various stakeholders that are required to facilitate Product Approval / Market Authorisation. The approvals are usually in the form of No Objection Certificates/Letters, Approval Letters, Licences etc.,
Optimus provides end-to-end Blood Product Registration Services as well as Authorised Agent Services to all importers and manufactures of blood and blood products. This end-to-end service offering will help you import, manufacture, test, conduct clinical trials and distribute your blood products in India (Market Authorisation), efficiently so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities.
This service offering includes Product Testing Vendor Identification & Management, various stakeholder regulatory submissions, approvals management, independent audit, regulatory reporting, regulatory dossier review and submission to the regulator.
Our services include the following :
- Regulatory Strategy Consulting and Liaison
- Complete Product Life Cycle Management
- Compilation of India specific submission dossiers
- Submission management leading to approvals from ALL Stakeholders
- India Specific Labelling and Patient Information / Instructions for Use leaflets
- Post marketing services including Complaint handling, Adverse incident Reporting & Management and product recall support as part of Product safety reporting, Query management, PSUR Writing & Submission activities
- All statutory Marketing Authorization holder’s requirements
- Act as your India Regulatory Department by Applying and Maintaining required approvals, Prepare and review regulatory submission material for compliance to India legislation etc.,