Licensing for Manufacturing and Selling ASU Drugs
Grant of Manufacture of Sale of ASU Drugs
Hospiraa assists in acquiring the initial license for manufacturing and selling ASU drugs. This service is available to manufacturers seeking to enter the ASU drug market or expand their product portfolio. Hospiraa guides clients through the application process, ensures compliance with regulatory requirements, and assists in compiling necessary documentation.
Renewal of License
Hospiraa provides support in renewing existing licenses for ASU drug manufacturing and sales. This service is for existing manufacturers with expiring licenses. Hospiraa facilitates the renewal process by keeping track of renewal deadlines, assisting in updating documentation, and liaising with regulatory authorities on behalf of the client.
Approval of Drug Formulations
Hospiraa offers guidance and assistance in obtaining regulatory approval for new ASU drug formulations. This service is for manufacturers developing new ASU drug formulations. Hospiraa advises on regulatory requirements for formulation approval, assists in preparing submission dossiers, and communicates with regulatory agencies throughout the approval process.
Good Manufacturing Certification (GMP)
Hospiraa provides assistance in adhering to Good Manufacturing Practices (GMP) standards for ASU drug manufacturing. This service is for manufacturers aiming to ensure quality and compliance in their production processes. Hospiraa conducts GMP assessments, provides recommendations for compliance improvement, and assists in implementing necessary changes to meet GMP standards.
Grant of Loan License to the Manufacturer and its Renewal
Hospiraa offers support in obtaining loan licenses for ASU drug manufacturing under another manufacturer’s license, along with renewal services. This service is for manufacturers seeking to produce ASU drugs under a loan license agreement. Hospiraa assists in negotiating loan license agreements, facilitates the application process, and ensures timely renewal of loan licenses as needed.
Free Sale Certificate
Hospiraa facilitates the issuance of Free Sale Certificates for demonstrating compliance when exporting ASU drugs. This service is for manufacturers exporting ASU drugs to international markets. Hospiraa assists in preparing and submitting Free Sale Certificate applications, liaises with regulatory authorities, and ensures timely issuance of certificates.
Additional Endorsement of Drug
Hospiraa provides assistance in obtaining endorsements for additional ASU drugs under existing manufacturing and sales licenses. This service is for manufacturers expanding their product portfolio. Hospiraa guides clients through the endorsement application process, ensures compliance with regulatory requirements, and facilitates communication with regulatory authorities.
Brand Name Change of Drug
Hospiraa offers support in the process of changing the brand name of ASU drugs while ensuring compliance. This service is for manufacturers rebranding their ASU drug products. Hospiraa advises on regulatory considerations for brand name changes, assists in updating documentation, and communicates with regulatory agencies to effect the change.
Non-Conviction Certification
Hospiraa assists in obtaining certification confirming the absence of criminal convictions related to drug manufacturing or distribution. This service is for manufacturers demonstrating compliance and integrity. Hospiraa assists in gathering necessary documentation, liaises with relevant authorities, and ensures timely issuance of certification.
Market Standing Certificate
Hospiraa facilitates the issuance of certificates verifying the market standing of ASU drugs. This service is for manufacturers seeking to demonstrate market credibility. Hospiraa assists in compiling relevant data, prepares submission dossiers, and communicates with regulatory authorities to obtain the certificate.
Performance Certificate
Hospiraa provides assistance in obtaining certificates attesting to the efficacy and quality of ASU drugs. This service is for manufacturers seeking to validate product performance. Hospiraa helps in gathering performance data, prepares supporting documentation, and liaises with regulatory agencies for certificate issuance.
Validity Certificate
Hospiraa offers support in obtaining certificates validating the validity period of ASU licenses. This service is for manufacturers ensuring compliance with license validity. Hospiraa monitors license validity, assists in applying for certificate renewal, and ensures timely issuance of validity certificates.
Unit Existence Certificate for Tender Activities
Hospiraa assists in obtaining certificates confirming the existence of manufacturing units for participation in tender activities. This service is for manufacturers participating in tender bids. Hospiraa verifies unit existence, prepares necessary documentation, and communicates with tendering authorities for certificate issuance.
