ABR is experienced in the preparation, critical review, assembly, and filing of the following regulatory submissions for pharmaceutical and medical device products:

 

Submissions

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United States

• Investigational Device Exemptions (IDEs)

• Pre-market Notification [510(k)] Applications

• Breakthrough Device Program Submissions

• De Novo Submissions

• Pre-market Approval Applications (PMAs)

• Investigational New Drug Applications (INDs)

• Q-Submissions

• Safer Technologies Program (STeP) Submissions

• Traditional and Abbreviated New Drug Applications (NDAs/ANDAs)

• Biologics License Applications (BLA)

• Chemistry, Manufacturing and Controls (CMC) Sections

• 505(b)(2) Applications (aka “Paper NDA”)

• Drug, Device and Biologic Master Files – Domestic and Foreign

• Certifications for Consent Decree Remediations, Bioequivalence, etc.

 

European Union and UK

• Technical Documentation (MDR and IVDR) and support through technical review

• Notifications to Notified Bodies and Authorized Representatives

 

Our Associates can work with your team to coordinate development of entire submissions, prepare turnkey inclusions (e.g., technical/manufacturing sections, software sections, clinical data analyses, validation reports, literature summaries, etc.), or any combination of participatory services.

 

 

Regulatory Support

In addition to submissions, ABR also provides expert guidance and assistance with many other approval-related activities.

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United States

• IND and IDE Preparation, Compilation, Submission, and Maintenance

• Preparation of, coaching, and participation in FDA Meetings at all levels:

  • Pre-submission Meetings

  •  Formal/Interactive Meetings

• Preparation of, coaching, and participation in Advisory Committee Meeting presentations

• Responses to FDA Inspection Form 483s and Warning Letters

• Reponses to Notified Body’s Technical Documentation Review

 

European Union and UK

• Assistance for drug/device combination device manufacturers under Rule 14

• Assistance for manufacturers of In Vivo origin products (EU Regulation 722/2012 & EN ISO 22442)

• Conformity Assessment procedures under MDR 2017/745

• Device classification and regulatory pathway consulting

• ISO 14971 risk management support

• MDR technical documentation gap analyses

• Notified Body observations and non-conformity responses

• Notified Body selection

• Reprocessing of disposable products under MDR

• Technical Documentation compilation

• UKCA Marking

• Unique Device Identifier (UDI)

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