ADVISORY 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.
I need help with...
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:
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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
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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
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CDER/CBER Submissions
(Drugs and Biologics)
Pre-Phase 1/Phase1
  • Pre-IND Meeting (and all meetings)
  • IND
  • End of Phase I Meeting
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Phase 2/3
  • IND Maintenance  
  • End of Phase II/Phase III
  • Pre-NDA Meeting
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Post-NDA Filing
  • Advisory Committee Meetings Slides
  • Post-market reporting
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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)
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Quality/Chemistry, Manufacturing and Controls (Module 3)
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Nonclinical Study Reports (Module 4)
Clinical Study Reports (Module 5)
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CDRH Submissions
(Devices and In Vitro Diagnostics)
Q-submission Meeting Requests
IDE (Investigational Device Exemption)
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510(k) or De Novo
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PMA (Premarket Approval Application)
HDE (Humanitarian Device Exemption)
Database - Tracks all submissions and interactions with the agency
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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:
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.
Quality Systems Management
Quality must be built into every product.
This often starts with design and moves through small scale manufacturing to commercial manufacture. Proxima can help with development of your initial quality systems.

We offer the following services related to quality:
We’ll work with you every step of the way, to manage your milestones.
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