Regulatory affairs services

Regulatory affairs services
Product Description

I. SERVICES

1. Submission of ANDA, NDA and IND applications with NMPA; (including the whole service from GAP analysis, compiling, submission, sample testing, CDE review procedure tracking and supplemental info preparation);

2. GAP analysis and application strategies setup before the submission to NMPA;

3. Pre-IND/NDA meeting with CDE; (including the preparation, application, tracking and CDE meeting support)

4. API, pharmaceutical excipients and packaging component filling and technical review with CDE;

II. OUR ADVANTAGES

1. Our consultants having a solid background in RA field including more than 10 years of drug registration experiences

2. Obtained more than 30 imported drug registration certificates, more than 7 Phase III clinical trial approval for an innovator. More than 5 Phase I clinical trial approval for a domestic biosimilar product. More than 10 Clinical trial approvals for imported new drugs

3. We have more than 5 experts that from CDE to support our work

Read more Show less

Beijing KingRaBroad (KRB) Consulting Inc

  • CN
  • 2022
    On CPHI since
  • 25 - 49
    Employees
Company types
Consultancy
View company profile
Categories
more categories Show less

Beijing KingRaBroad (KRB) Consulting Inc

  • CN
  • 2022
    On CPHI since
  • 25 - 49
    Employees
Company types
Consultancy
View company profile

More Products from Beijing KingRaBroad (KRB) Consulting Inc (2)

  • GMP Consultation

    Product GMP Consultation

    Onsite/offsite gap analysis of the quality management system for pharmaceutical companies against Chinese GMP, cGMP, Eudralex GMP, PIC/S GMP, and WHO GMP guidelines; Provide recommendations on gap-bridging; Carry out mock up audits and assist in correction of findings; Provide onsite technical support and ...
  • Translation services

    Product Translation services

    We have professional translators that can provide: - English & Chinese interpretation services during international GMP audits; - English & Chinese interpretation services during communication with NMPA and other authorities; - English & Chinese translation of audit reports / CAPA reports; - En...