Pharma Regulatory Services in USA - Overview
Pharmaceutical market in the United States of America (USA) is considered the best for its established Regulatory framework. The US Food and Drug Administration (US FDA) regulates the manufacture, import, distribution and marketing of pharma products in the country. The term pharma in the USA overarches numerous products and each of them possess a different approach to obtain market authorization. Pharmaceutical products in the country must be registered with the FDA through New Drug Application (NDA) for an Investigational New Drug (IND), Abbreviated New Drug Application (ANDA) for a generic drug, and through Biologics License Application (BLA) for a new biologic product.
NDAs and ANDAs are further divided into:
- Stand-alone NDA - Submitted under section 505(b)(1) and approved under section 505(c) of the FD&C Act
- 505(b)(2) Application is an NDA - Submitted under section 505(b)(1) and approved under section 505(c) of the FD&C Act
- ANDA - Submitted and approved under section 505(j) of the FD&C Act
- Petitioned ANDA - Submitted and approved under section 505(j) of the FD&C Act
With an extensive Regulatory criterion in existence, it might be challenging for new market entrants to understand and implement the critical aspects related to dossier compilation and submissions while approaching for market authorization with the FDA. With requirement of a US agent for foreign applicants, it may also be a difficult scenario to appoint a dependable person in the region.
With proven Regulatory capabilities, Freyr supports sponsors in ensuring their NDAs and ANDAs compiled and submitted as per the USFDA requirements. Headquartered in USA, Freyr offers strategic and intelligent Regulatory services for successful and on-time submissions for all variants of applications.
Pharma Regulatory Services in USA
Freyr Expertise
- Compilation and Submission support in electronic common technical document (eCTD) for:
- Investigational New Drug (IND) Applications
- New Drug Applications (NDAs)
- Abbreviated New drug applications (ANDAs)
- Biologics License Applications (BLAs)
- Drug Master Files (DMFs)
- Preparation of Regulatory strategy for 505 (b)(2) and ANDA submissions
- Regulatory support during research and development. For example,
- Controlled correspondence (CC) submission for Inactive Ingredient Guide (IIG) related or Q1/Q2 sameness and tracking
- Active Pharmaceutical Ingredient (API) information evaluation
- Composition evaluation for IIG
- Exhibit batch documents evaluation (API, excipients and finished product specs, stability protocol, hold time protocol, process validation protocol, master formula record)
- Evaluation of the product by gap analysis of source data from R&D and manufacturing site (executed data) for USFDA specific Regulatory and submission requirements
- Act as an US Agent for foreign applicants
- Pre-submission administrative activities like ANDA number request, labeler code request, establishment SPL submission and GDUFA cover sheet generation
- Compilation and submission of the dossier in eCTD format
- Consultation during the ongoing, completed developments and manufacturing of the finished product
- Amendments (query responses and unsolicited information) compilation and submission to all types of submissions
- Post-approval (CBE-0, CBE-30 & PAS) and life cycle management (annual report) compilation and submission
