Amcogen

Regulatory Affairs| Regulatory Query Handling| AMCOGEN
Pharmacy Regulatory Query Handling

Regulatory

Drug Registration | Regulatory Query Handling | BE Studies | Fully Compliant GMP Documents

To support product development and supply chain programme, Amcogen Alliance is actively support your local regulatory registration. Through our Regulatory team, we work closely in line with your guideline and also with local regulatory expert which enable us to provide prompt and straightforward assistance and faster regulatory approval for submitted dossiers to get things done right in the first time.

Our Partners Gets Following Benefits:

  • Advise on product registration requirement and bioequivalence study design.
  • Clear list of documents for product registration and approval requirement to enable them to meet and decide what is exactly needed.
  • Prepare dossiers that meet the local mandatory requirements of regulatory authorities
  • Implementation of regulatory requirements
  • Dossier and data compliance reviews
  • Regulatory query handling
  • Resolution of complex regulatory issues
  • Review of GMP documents
  • Identification of potential products
  • Development Strategies and Project Management

Clinical Development/ Bioequivalence Studies for generic product.

  • Review of Protocol and CSRs
  • Review of PK data from pilot and pivotal studies
  • Monitoring of studies
  • Audit of sites and CROs
  • Compliance advice and monitoring
  • Strategies for BE Studies