Navigate US regulations with confidence
The US Food and Drug Administration (USFDA) evaluates pharmaceutical products based on their safety, efficacy, quality and manufacturing controls before they can be marketed. RIAR Consulting supports companies through development, registration and post-approval stages.
Regulatory support for one of the world’s most significant markets
The United States is one of the world’s most significant pharmaceutical markets, with a regulatory framework that requires detailed scientific, technical and quality documentation.
RIAR Consulting supports pharmaceutical companies in understanding and addressing USFDA regulatory requirements throughout the product development, registration and post-approval stages.
For medical devices, we help clients prepare and submit 510(k), PMA and other regulatory filings, from documentation review to risk management and labelling compliance.
Our USFDA regulatory services
Structured support across the product lifecycle, from pathway assessment to post-approval change.
- 01
Regulatory strategy and pathway assessment
- Identification of applicable regulatory pathways
- Regulatory classification and product eligibility assessment
- Applicable FDA requirements for new drugs, generic drugs and biological products
- Regulatory gap assessment and submission planning
- 02
Dossier preparation and submission support
- New Drug Applications (NDA)
- Abbreviated New Drug Applications (ANDA)
- Biologics License Applications (BLA), where applicable
- Investigational New Drug (IND) application support
- Preparation, review and compilation of CTD/eCTD documentation
- Submission-readiness assessment
- 03
CMC and quality documentation
- Chemistry, Manufacturing and Controls (CMC) documentation review
- Drug substance and drug product information
- Manufacturing process and control documentation
- Specifications, analytical methods and validation documentation
- Stability data and supporting technical reports
- 04
Regulatory queries and deficiency management
- Assessment of FDA information requests and deficiency observations
- Preparation of technical responses and supporting documentation
- Coordination across technical and quality teams
- Addressing gaps identified during application review
- 05
Post-approval regulatory support
- Regulatory impact assessment of product and manufacturing changes
- Applicable post-approval submissions and variations
- Renewals and ongoing regulatory maintenance, where applicable
- Documentation updates and lifecycle management
- 06
FDA inspection and compliance support
- GMP compliance gap assessment
- Inspection-readiness documentation review
- Support in preparing responses to regulatory observations
- Quality system and documentation review
- 07
Medical devices and IVDs
- 510(k) and PMA filings
- Documentation review and risk management
- Labelling compliance review
- Submission preparation and follow-up
A structured approach to the US market
Each engagement follows the same structured sequence, adapted to the product and the applicable FDA pathway:
- Understanding the product, its development or marketing status and your regulatory objectives
- Assessing the applicable regulatory pathway, authority and documentation expectations
- Identifying gaps in technical, quality and administrative documentation
- Preparing, reviewing and compiling documentation to the market’s requirements
- Supporting submission readiness, authority correspondence and query management
- Lifecycle support for variations, renewals, regulatory changes and documentation maintenance
RIAR works to help companies develop a structured regulatory approach for the US market while maintaining alignment with applicable FDA requirements.
How VERA 2.0 supports this sector
FDA review covers manufacturing controls as well as the dossier. VERA 2.0 gives manufacturing teams continuous visibility into the plant conditions that sit behind that documentation.
- VERA 2.0
cGMP manufacturing visibility
Continuous visibility into facility, environmental and equipment conditions relevant to current good manufacturing practice, where supported by connected systems.
- VERA 2.0
Earlier identification of deviations
Anomaly identification highlights unusual operating patterns early, so authorised personnel can investigate before they affect a batch.
- VERA 2.0
Event records for investigations
Structured records of events, observations and advisories support deviation investigations and inspection-readiness reviews.
- VERA 2.0
Lifecycle change awareness
Operational context on equipment and process conditions helps teams assess manufacturing changes that may carry regulatory impact.
VERA 2.0 is an advisory decision-support system. It does not write to or control plant systems, and it does not replace the site’s quality management system, validated records or regulatory determinations. Capabilities depend on the systems connected at each site.
Planning a US FDA submission?
Whether you are preparing a new application, responding to FDA observations or managing post-approval changes, RIAR Consulting can support your regulatory objectives.