DSI (US Agent Services)
Acumen Fiscal Agent
Regulatory consulting firm providing FDA U.S. Agent services for foreign establishments, including registration, listing, communication with FDA, and inspection / compliance support.
DSI (DS InPharmatics) provides FDA U.S. Agent services for international pharmaceutical companies and other FDA-regulated products. They act as the required point of contact between foreign establishments and the FDA, handling establishment registration, product listing, regulatory communications, inspection coordination, and compliance support. DSI serves as your trusted U.S. Agent, ensuring adherence to all relevant FDA regulations and serving as a dependable liaison between your organization and the FDA.
About
**Who they are**
DSI (US Agent Services), a ProductLife Group company, is a regulatory, technical, and project management consulting firm established in 2007. They specialize in providing services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
**Expertise & scope**
* Assisting global sponsors with product development, regulatory compliance, and project management challenges.
* Contributing to investigational applications, New Drug Applications (NDAs/BLAs), and briefing book resources for collaborations with regulatory authorities like the EMA and US FDA.
* Providing expertise in Chemistry, Manufacturing, and Controls (CMC) strategy, operations, and submission content development.
* Offering solutions for small molecules, biologics, veterinary medicine, and cellular and gene therapies.
* Specializing in regulatory affairs, CMC, and quality assurance.
**Reputation / proof points**
* Founded in 2007 by Edward Narke and Anthony Durning.
* Partnered with over 200 unique sponsors globally.
* Contributed to over 100 investigational applications and 25 NDAs/BLAs.
* Became part of ProductLife Group in April 2021.
DSI (US Agent Services), a ProductLife Group company, is a regulatory, technical, and project management consulting firm established in 2007. They specialize in providing services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
**Expertise & scope**
* Assisting global sponsors with product development, regulatory compliance, and project management challenges.
* Contributing to investigational applications, New Drug Applications (NDAs/BLAs), and briefing book resources for collaborations with regulatory authorities like the EMA and US FDA.
* Providing expertise in Chemistry, Manufacturing, and Controls (CMC) strategy, operations, and submission content development.
* Offering solutions for small molecules, biologics, veterinary medicine, and cellular and gene therapies.
* Specializing in regulatory affairs, CMC, and quality assurance.
**Reputation / proof points**
* Founded in 2007 by Edward Narke and Anthony Durning.
* Partnered with over 200 unique sponsors globally.
* Contributed to over 100 investigational applications and 25 NDAs/BLAs.
* Became part of ProductLife Group in April 2021.
Additional information
DSI InPharmatics focuses on providing a real-world, field-tested viewpoint to guide new products from pre-IND enabling work through clinical trials to regulatory approvals and post-approval lifecycle maintenance. They emphasize open exchange of information and directness, offering authentic assessments, representative timelines, dependable technical advice, and truthful submissions based on current and forward-thinking regulatory strategies. Their approach is not one-size-fits-all, positioning them as an extension of a client's internal team.
Key Highlights
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Founded in 2007, DSI has over a decade of experience assisting global sponsors with product development and regulatory compliance.
Source
“Founded in 2007 by Edward Narke and Anthony Durning, who previously served more than 25 years combined at small emerging biotech, DSI is a full-service regulatory drug development consulting firm for pharmaceuticals, biologics and new drug and delivery platforms.”
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Partnered with over 200 unique sponsors globally, contributing to numerous investigational applications and New Drug Applications (NDAs/BLAs).
Source
“Over the last decade, we have partnered with more than 200 unique sponsors not only here in the US but globally, having contributed efforts to more than 100 investigational applications, 25 full and supported new Drug Application (NDAs/BLAs))”
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Provides specialized consulting for pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Source
“DSI provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.”
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Offers expertise in Chemistry, Manufacturing, and Controls (CMC), including strategy, operations, and submission content.
Source
“Whether advocating CMC strategy, directing CMC operations, or developing CMC submission content that represents the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.”
Certifications & Trust Signals
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Became part of ProductLife Group in April 2021, integrating with a broader network of services.
Source
“In April 2021 we were thrilled to announce that DSI has just become part of ProductLife Group.”
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Provides support for veterinary drug and biologic approvals, navigating FDA CVM and USDA CVB regulatory frameworks.
Source
“Navigating the regulatory landscape for veterinary pharmaceuticals and biologics can be complex. The U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM) and the U.S. Department of Agriculture’s Center for Veterinary Biologics (USDA CVB) oversee different aspects of veterinary product approvals.”
Buyer Snapshot
Best for
- Companies seeking regulatory, technical, and project management consulting for pharmaceuticals, biopharmaceuticals, and cellular/gene therapies.
- Emerging biotech firms needing CMC strategy and submission support.
How engagement typically works
- Direct and open communication.
- Tailored strategies, not one-size-fits-all.
Typical deliverables
- Regulatory submission content (IND, NDA/BLA).
- CMC strategy and operations guidance.
- Project management for drug development.
- Due diligence reports.
- Veterinary medicine regulatory support.
Good to know
- Best when clients require deep regulatory and CMC expertise for complex healthcare products.
HQ:
Mesa, US
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Drugs, Pharmaceuticals
Portfolio:
26-100
Onboarding time:
1–3 days
Pricing model:
Onboarding + annual retainer
Starting from:
USD 950
Included services:
FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Product Type:
drugs
Service Types:
US Agent Services, FDA Registration/Listing Support, Inspection Support, FDA Submissions (510(k), PMA, IDE, etc.), Product/Device Listing, Regulatory Consulting
Additional us_agent_fda Details
Included Services Detailed
Designation support and onboarding checklist for foreign establishment U.S. Agent setup, FDA communications receipt, acknowledgment, and routing to your designated contacts, Inspection scheduling support and operational readiness escalation (when applicable), Annual registration renewal reminders and administrative coordination
Excluded Services
Acting as importer of record, Commercial distribution management, Legal representation in enforcement actions
Onboarding Steps
Engage early with regulatory authorities, develop a comprehensive regulatory strategy, streamline manufacturing and quality control.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Pharmaceuticals, Biopharmaceuticals, Cellular and Gene Therapy Products, Veterinary Drugs, Veterinary Biologics
Registration Support
Implied through regulatory consulting services for foreign establishments.
US Entity State
PA (Harleysville, PA)
Recall Support
No explicit mention of FDA recall and field action support.
Inspection Support
Implied through compliance support.
Emergency Contact24x7
No explicit mention of 24/7 emergency contact availability.
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