Get quicker regulatory approval by leveraging our experience in submitting comprehensive dossiers in regulatory countries.
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.