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 since April 2021, is a full-service regulatory drug development consulting firm founded in 2007. They specialize in providing regulatory, technical, and project management consulting services to healthcare product companies.
**Expertise & scope**
* Expertise in pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
* Services encompass CMC strategy, CMC operations, and CMC submission content development.
* Support for product development, regulatory compliance, and project management challenges.
* Experience with investigational applications, New Drug Applications (NDAs/BLAs), and briefing book resources for FDA and EMA collaborations.
* Specialized solutions for small molecules, biologics, veterinary medicine, and cellular and gene therapy.
* Focus on Chemistry, Manufacturing, and Controls (CMC), Quality Assurance, and Program Management.
* Guidance on regulatory affairs and due diligence.
**Reputation / proof points**
* Founded in 2007.
* Part of ProductLife Group since April 2021.
* Partnered with over 200 unique sponsors globally.
* Contributed to over 100 investigational applications and 25 NDAs/BLAs.
* Provides a real-world, field-tested viewpoint on product development from pre-IND to post-approval lifecycle maintenance.
DSI (US Agent Services), a ProductLife Group company since April 2021, is a full-service regulatory drug development consulting firm founded in 2007. They specialize in providing regulatory, technical, and project management consulting services to healthcare product companies.
**Expertise & scope**
* Expertise in pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
* Services encompass CMC strategy, CMC operations, and CMC submission content development.
* Support for product development, regulatory compliance, and project management challenges.
* Experience with investigational applications, New Drug Applications (NDAs/BLAs), and briefing book resources for FDA and EMA collaborations.
* Specialized solutions for small molecules, biologics, veterinary medicine, and cellular and gene therapy.
* Focus on Chemistry, Manufacturing, and Controls (CMC), Quality Assurance, and Program Management.
* Guidance on regulatory affairs and due diligence.
**Reputation / proof points**
* Founded in 2007.
* Part of ProductLife Group since April 2021.
* Partnered with over 200 unique sponsors globally.
* Contributed to over 100 investigational applications and 25 NDAs/BLAs.
* Provides a real-world, field-tested viewpoint on product development from pre-IND to post-approval lifecycle maintenance.
Additional information
DSI InPharmatics emphasizes a pragmatic approach to drug development, combining subject-matter expertise with project management. They advocate for open information exchange and directness, avoiding a one-size-fits-all strategy. Buyers can expect authentic assessments, representative timelines, dependable technical advice, and truthful submissions based on current and forward-thinking regulatory strategies. Their services are designed to act as an extension of a client's internal team, providing a 'deeper department' for critical CMC and regulatory affairs.
Key Highlights
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Founded in 2007, DSI InPharmatics has over a decade of experience in drug development consulting.
Source
“Founded in 2007 by Edward Narke and Anthony Durning...”
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Part of the ProductLife Group since April 2021, expanding global reach and resources.
Source
“In April 2021 we were thrilled to announce that DSI has just become part of ProductLife Group.”
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Contributed to over 100 investigational applications and 25 full/supported New Drug Applications (NDAs/BLAs).
Source
“...having contributed efforts to more than 100 investigational applications, 25 full and supported new Drug Application (NDAs/BLAs))”
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Provides specialized solutions for veterinary medicine, including navigating FDA CVM and USDA CVB pathways.
Source
“FDA CVM regulates veterinary pharmaceuticals, including: USDA CVB oversees veterinary biologics, including:”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies developing pharmaceuticals, biopharmaceuticals, and cellular/gene therapies.
- Emerging biotech firms needing CMC and regulatory strategy support.
- Global sponsors seeking US regulatory compliance and development guidance.
How engagement typically works
- Direct and authentic communication.
- Collaborative, acting as an extension of the client's team.
- Tailored strategies, not one-size-fits-all.
Typical deliverables
- CMC strategy and operations plans.
- Submission content for NDAs/BLAs.
- Regulatory compliance guidance.
- Project management for drug development.
- Due diligence reports.
Good to know
- Best when requiring specialized expertise in CMC, regulatory affairs, and project management for complex healthcare products.
HQ:
Mesa, US
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
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, but not explicitly stated as 'establishment registration'.
US Entity State
Pennsylvania (based on P.O. Box address)
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.
