PHARMACEUTICAL PRODUCTS CONSULTING
Products’ Registration & Maintenance
The registration of Pharmaceutical and biologic products is a complex and lengthy process that is becoming more challenging for companies that are developing new technologies and that have to comply with very demanding regulatory requirements and health authorities.
Global Regulatory Partners (GRP) RA team has the expertise and long-term experience preparing, compiling and submitting successfully to health authorities, the registration dossiers of pharmaceutical and biologic products from different therapeutic areas and despites the complexity of their technologies.
Through many years of experience working with different health authorities such FDA, EMA, CFDA, ANVISA, TGA, PMDA, during Pharmaceutical and Biologic products registration process, GRP RA team was able to build close working relationships with those health authorities.
GRP RA team can prepare and submit for you the following applications to health authorities:
- Investigational New Drug (IND) Applications
- Clinical Trial Authorization (CTA) applications
- Marketing Authorization Application (MAA)
- New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- Biologics Licensing Application (BLA)
During the review process, GRP RA team will prepare and submit the responses to health authorities’ queries as needed and will provide the necessary regulatory support till you receive the formal application approval.
After approval, GRP RA team will maintain your IND/CTA application or your Marketing Authorization by providing the following services:
- Preparation and submission of IND, CTA, applications amendments.
- Preparation and submission of NDA, BLA, MAA, ANDA amendments.
- Preparation and submission of Annual Reports.
Contact us today to learn more about how we can assist your company register and maintain the registration of your products with health authorities.