Regulatory Consulting Services

Regulatory Consulting and Project Management Services

Whether your product is a medical device, biologic, or drug, careful consideration of regulatory requirements is key. Each milestone must be planned with your business strategy, development timeline, and regulatory pathway in mind. And, every challenge must be managed strategically. Your entire development process could depend on it.

Proxima’s attention to detail and rapid workflow allows us to work with you to get the job done quickly and efficiently. Whether you need help executing an entire regulatory strategy, filing your submissions, or conducting a meeting with the agency, we can provide fast, thorough, and decisive consulting services.

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Regulatory strategy

Regulatory Submissions

Regulatory Liaison

CMC Regulatory Services

Clinical Development

Quality Systems Management

Regulatory Strategy

We can develop a competitive regulatory strategy that considers market advantage.

Our regulatory strategic services include:

Generation of Regulatory Development Plans
End-point research
Determination of past precedence
Therapeutic area analyses
Competitor Analysis
Gap Analyses for:
INDs, NDAs
BLAs
IDEs, 510(k)s, De Novo, PMA, HDE
Negotiation of clinical end-points and other program needs with regulators
Creation of Instructions for Use, Draft Package Inserts, or Target Product Profiles
Manage project from conception through NDA, BLA, 510(k), HDE, or PMA approval
Perform/Prepare information for Due Diligence

Regulatory Submissions

No matter the type of product or size of your team, some extra expertise, or even just a helping hand, can help speed up your development.

We can provide the following regulatory affairs consulting services at any stage of development:

All Stages and Products

Annual Reports
Safety Reporting
Investigator Information
Review of Marketing Materials & Press Releases

General Reports

Regulatory Strategy, including pathway and timeline
Regulatory information - Analysis of publicly available information that could have an impact on the development plan
Regulatory tracking database - Tracks all submissions and interactions with the agency

CDER/CBER Submissions
(Drugs and Biologics)

Pre-Phase 1/Phase1

Pre-IND Meeting (and all meetings)
IND
End of Phase I Meeting

Phase 2/3

IND Maintenance
End of Phase II/Phase III
Pre-NDA Meeting

Post-NDA Filing

Advisory Committee Meetings Slides
Post-market reporting

New Drug Application/Biologics Licensing Application
All work will be provided in a Common Technical Document (CTD) format

Administrative section and Prescribing Information (Module 1)

Common Technical Document Summaries

Quality overall summary (Module 2.3)
Nonclinical Overview (Module 2.4)
Clinical Overview (Module 2.5)
Nonclinical Written and Tabulated Summaries (Module 2.6)
Clinical Summary (Module 2.7)

Quality/Chemistry, Manufacturing and Controls (Module 3)

Nonclinical Study Reports (Module 4)

Clinical Study Reports (Module 5)

CDRH Submissions
(Devices and In Vitro Diagnostics)

Q-submission Meeting Requests

IDE (Investigational Device Exemption)

510(k) or De Novo

PMA (Premarket Approval Application)

HDE (Humanitarian Device Exemption)

Database - Tracks all submissions and interactions with the agency

Regulatory Liaison

Meeting with regulatory agencies is an important part of developing a strong strategy that is aligned with the FDA’s thinking.

For any meetings, we can provide the following activities:

Meeting package preparation
Rehearsals
Agendas
Planning
Attendance
Minutes

The following are typical meeting types for therapeutics and devices:

CDER/CBER Meetings (Drugs and Biologics)

Pre-IND Meeting (and all meetings)

This is the time to discuss the requirements for opening an IND with the Agency. Our goal is to have the meeting end with as much clarity as possible, so that you can effectively get development underway.

End of Phase II/Pre-Phase III Meeting

At this meeting, you will present your Phase III and submission strategies to make sure that you and the FDA agree prior to the start of your Phase III trials.

Pre-NDA Meeting

Now that your Phase III clinical trials are complete, it’s time to meet with the FDA to prepare for the filing of your NDA. At this meeting, you’ll discuss FDA’s expectation for content of the submission, including the pivotal clinical trial data, CMC information, and the ISS and ISE.

Advisory Committee Meeting

Advisory committees provide FDA with independent advice from outside experts on issues related to drugs, biologics, and medical devices. These meetings can involve you, as a sponsor, to discuss your product and often require extensive preparation. At this meeting, both you and FDA will present. Then, you will be asked questions. The panel of experts will take a vote on how to advise the FDA.

CDRH Meetings (Devices and In vitro Diagnostics)

Informational Meeting

This meeting is for the purpose of sharing information with the FDA without the expectation of getting feedback. These meetings may be held to introduce the FDA to a new device or provide information about ongoing development.

Determination Meeting

Available only to PMA and PDP applicants, a determination meeting will determine the type of valid scientific evidence needed to establish safety and effectiveness. FDA’s determination is binding upon the Agency unless it would be contrary to public health.

Agreement Meeting

Unlike Determination meetings, agreement meetings can be utilized by any Class III product or implant, including 510(k) eligible devices. This meeting allows sponsors and the FDA to reach an agreement about the key parameters for the investigational plan. The agreement is binding upon the agency and may only be changed with written agreement from the applicant or when there is knowledge of a scientific issue necessary for determining safety and effectiveness.

Pre-submission meeting

Pre-submission meetings allow you to meet with the FDA early on to get feedback on your regulatory pathway, non-clinical testing plan, and/or clinical protocol. These meetings are not required but are highly recommended.

CMC Regulatory Services

Customized Solutions for Small Companies

CMC strategy and management of drug substance and drug product
Failure investigations and clinical batch salvage strategies
Full regulatory affairs support and technical project management
Man-in-plant services (or woman)

Active Pharmaceutical Ingredient (API) and Drug Product Program Management

Contract manufacturing organization (CMO) selection support and project management
Scientific/project-specific site visits and cGMP audits to evaluate vendor staff and facility capability to execute the program• Scientific interpretation of manufacturing and analytical results
Scientific interpretation of manufacturing and analytical results
Alternative approaches to keep development programs on schedule
Advice on setting specifications and assigning product shelf-life
Direct interactions and negotiations with regulatory agencies
Supplier performance meetings

Clinical Development

Our goal is to deliver the best clinical data, which means providing you with expertise early on.

We utilize a breadth of knowledge in clinical, biostatistics, regulatory, and health economics, optimizing our strategies and tools to guide you.

Our clinical development and trial design services include:

Clinical hypothesis consultation
Endpoint selection and confirmation
Health economics planning
Statistical sample size calculation and power analysis
Randomization
Scenario building

Protocol writing and review
Resource planning
Site selection
Cost estimation
Database Design and/or Case report form (CRF) design
Literature review

When clinical studies present specific challenges, we tap into our creative thinking skills, along with our years of expertise, to come up with innovative solutions.