BLA Regulatory
BLA Regulatory offers expert FDA regulatory consulting and U.S. Agent representation for drug and medical device companies. They facilitate IND filings, clinical trial strategy, and navigate complex regulatory pathways.
BLA Regulatory is a specialized consulting firm providing comprehensive regulatory services for drug and medical device companies seeking to enter or operate within the U.S. market. With extensive experience in IND filings, clinical trial registration, and strategy development, they act as a crucial U.S. Agent, facilitating interaction with the FDA on behalf of foreign sponsors. Their expertise spans the entire product lifecycle, from initial research and nonclinical development through submission, approval, and post-market maintenance. BLA Regulatory excels in formalizing meetings with regulatory agencies, providing critical regulatory insight, and ensuring operational efficiency. They offer tailored end-to-end approaches, translating complex regulatory requirements into actionable plans to expedite product development and market entry. BLA Regulatory's services are designed to support companies, particularly startups and small biotechs, in navigating the intricacies of FDA compliance. They offer guidance on medical device classification through 513(g) requests, develop robust IND/CTA strategies with NDA/BLA submissions in mind, and provide essential support for clinical trial recruitment and registration. Their team of FDA-experienced experts, industry leaders, and regulatory professionals ensures clients receive competent and reliable support to achieve their development and commercialization goals.
About
**Who they are**
BLA Regulatory provides expert FDA regulatory consulting and U.S. Agent representation for drug and medical device companies. They facilitate IND filings, clinical trial strategy, and navigate complex regulatory pathways.
**Expertise & scope**
* U.S. Agent Representation: Facilitates interaction with the FDA for foreign sponsors, offering regulatory insight and operational efficiency beyond basic communication.
* IND Filing & Maintenance: Assists in compiling robust data sets for Investigational New Drug Applications, covering drug manufacturing, purity, potency, animal testing, and human trial plans.
* Health Authority Meetings: Organizes and prepares for formal meetings with regulatory agencies to discuss development programs, resolve issues, and obtain approvals for clinical trials or product licenses.
* Regulatory Strategy Development: Creates tailored end-to-end approaches for product development, from research and nonclinical stages through submission, approval, and maintenance.
* Gap Analysis: Conducts logical and scientific reviews of available information to forecast product success and inform preliminary discussions with regulatory agencies.
* Medical Writing: Develops quality regulatory, clinical, and scientific documents, adhering to guidelines such as ICH-GCP, FDA, and EMA, and managing submissions in eCTD and CTD modules.
**Reputation / proof points**
* Functions as an extension of the client's internal team, ensuring compliance throughout the product development and marketing program.
BLA Regulatory provides expert FDA regulatory consulting and U.S. Agent representation for drug and medical device companies. They facilitate IND filings, clinical trial strategy, and navigate complex regulatory pathways.
**Expertise & scope**
* U.S. Agent Representation: Facilitates interaction with the FDA for foreign sponsors, offering regulatory insight and operational efficiency beyond basic communication.
* IND Filing & Maintenance: Assists in compiling robust data sets for Investigational New Drug Applications, covering drug manufacturing, purity, potency, animal testing, and human trial plans.
* Health Authority Meetings: Organizes and prepares for formal meetings with regulatory agencies to discuss development programs, resolve issues, and obtain approvals for clinical trials or product licenses.
* Regulatory Strategy Development: Creates tailored end-to-end approaches for product development, from research and nonclinical stages through submission, approval, and maintenance.
* Gap Analysis: Conducts logical and scientific reviews of available information to forecast product success and inform preliminary discussions with regulatory agencies.
* Medical Writing: Develops quality regulatory, clinical, and scientific documents, adhering to guidelines such as ICH-GCP, FDA, and EMA, and managing submissions in eCTD and CTD modules.
**Reputation / proof points**
* Functions as an extension of the client's internal team, ensuring compliance throughout the product development and marketing program.
Additional information
BLA Regulatory emphasizes a tailored, end-to-end approach to regulatory services, acting as an extension of a client's internal team. Their services span the entire drug development lifecycle, from initial product research and nonclinical studies to clinical development, submission, approval, and post-market maintenance. They specialize in navigating the FDA apparatus, offering regulatory insight and operational efficiency, particularly for foreign sponsors requiring U.S. Agent representation. Their expertise includes preparing for and conducting meetings with regulatory agencies, developing comprehensive IND filing strategies, and performing gap analyses to assess product viability. Clients can expect a focus on translating regulatory requirements into actionable plans to ensure product compliance and facilitate market entry.
Key Highlights
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Provides U.S. Agent representation for foreign sponsors to interact with the FDA.
Source
“Foreign sponsors of drug applications who want to conduct business in the United States need an authorized U.S. Agent to interact with the FDA on their behalf.”
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Specializes in IND Filing & Maintenance, compiling robust data sets for regulatory review.
Source
“BLA Regulatory works with our clients, the sponsors, to present the best case to the regulators by compiling a robust data set describing how the drug is made and determined to be pure and potent...”
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Offers comprehensive regulatory strategy development from product research to post-approval maintenance.
Source
“Our scope of services can start from product research, nonclinical, and clinical development, right up to the submission, approval, and the maintenance stage.”
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Expertise in medical writing for regulatory, clinical, and scientific documents, adhering to FDA and EMA guidelines.
Source
“BLA Regulatory has a comprehensive understanding of various regulatory guidelines such as ICH-GCP, FDA, and EMA.”
Certifications & Trust Signals
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Functions as an extension of the client's internal team to ensure compliance.
Source
“BLA functions as an extension of your internal team. We leverage our strengths and experience to ensure compliance of your product development and marketing program through the services we provide.”
Buyer Snapshot
Best for
- Foreign drug and medical device companies needing FDA representation.
- Companies seeking assistance with IND filings and clinical trial strategy.
- Businesses requiring expert navigation of complex FDA regulatory pathways.
How engagement typically works
- Acts as an extension of the client's internal team.
- Provides tailored, end-to-end strategic and operational support.
- Focuses on regulatory insight and operational efficiency.
Typical deliverables
- U.S. Agent Representation services
- IND Filing and Maintenance support
- Health Authority Meeting preparation and execution
- Regulatory Strategy Development plans
- Gap Analysis reports
- Medical Writing for regulatory documents
Good to know
- Best when requiring specialized FDA regulatory expertise for product development and market entry.
HQ:
Gaithersburg, US
Languages:
English
Timezones:
America/New_York
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, Drugs
Portfolio:
6-25, 26-100, 100+
Onboarding time:
2–7 days
Pricing model:
Retainer
Starting from:
USD 1,700
Included services:
FDA communications handling, Establishment registration support, Product listing assistance, Regulatory submission support, Compliance consulting
Product Type:
devices
Service Types:
US Agent Services, FDA Registration/Listing Support, FDA Submissions (510(k), PMA, IDE, etc.), Regulatory Consulting
Additional us_agent_fda Details
Product Types
Drugs, Medical Devices
Registration Support
No explicit mention
Recall Support
No explicit mention
Inspection Support
No explicit mention
Emergency Contact24x7
No explicit mention
US Entity State
MD
Onboarding Steps
No explicit mention
