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

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• Regulatory strategy and consulting:

  • Provide expert guidance on optimal development pathways, helping companies develop sound regulatory strategies aligned with their product's target markets and regulatory requirements.

  • Conduct gap assessments, identify potential challenges, and offer strategic advice on meeting regulatory expectations from early development through submission and approval.

• Regulatory submissions and approvals:

  • 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.

  • Assist in preparing, compiling, and submitting various regulatory documents to agencies like the FDA, EMA, and other international bodies including:

             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

• Clinical Trial Applications (CTAs)

• Interactions with regulatory authorities:

  • Facilitate and manage communications with regulatory bodies, acting as a liaison between the sponsor and the agencies.

  • Assist in preparing for and participating in scientific advice meetings, crucial milestone discussions, and other strategic interactions, ensuring clear and compliant communication of development plans and data.

• Post-approval support:

  • Regulatory services extend beyond initial approvals, including post-marketing surveillance, pharmacovigilance, and support for maintaining ongoing compliance and regulatory updates throughout the product's lifecycle. 

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