Medical & Regulatory Affairs Consultants

Aligned with FDA policy on Accelerating Cures

Advocate for Greater Use of Real World Evidence

Supporting Novel Alternative Preclinical Models

Aligned with Model Informed Drug Development

Supporting innovators from early development through approval since 1991.

Overview

Overview

We are a highly focused regulatory affairs consulting group dedicated to supporting pharmaceutical and emerging biotechnology companies with advanced therapies by navigating complex regulatory pathways. With years of experience in all facets of regulatory affairs, including compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Documentation Practice (GDP), we are able to navigate the regulatory landscape with skill and efficiency. Our in-house FDA submissions group provides strategic and operational support for rapid ESG NG, CDER Direct, eSubmitter, EDLRS, and SPL submissions. We have made over 1000 submissions in the past several years.

Our team has extensive experience working with the FDA to resolve issues, procedural and scientific, including FDA meeting preparation and representation, overall product development strategy, and critical, time-sensitive submissions to CDER and CBER, including tissue-based products, peptides, and large molecules. We are also experienced with drug device combinations for drugs, drugs, and biologics.

Our own GDP SOPs govern our document and submission management processes. File exchange with clients is in accordance with the current cybersecurity and document governance standards of the cloud services we use to interface with you.

Where Every Piece Has a Purpose

What We Do

To accelerate the development and approval of innovative therapies by providing clear, strategic, and compliant medical and regulatory guidance, compliant with all 3 components of product development. Early-stage guidance for compliant small-scale DS and DP manufacturing, translation of dose from disease models, pharm-tox dose translation to man, including MABEL, HTSD, and NOAEL. We believe your FIH studies should be supported by GxP requirements, include appropriate safety monitoring (e.g., SRCs), and use appropriate study designs (e.g., 3+3, CRM, and Bayesian methods).

We use AI for all grammar and spell checking; two software types are applied to each regulatory document. We also use AI to generate Excel-ready export sheets for tabular summaries when necessary to clarify points in narrative studies.

  • Therapeutic Focus

    • Cell and gene therapies
    • Monoclonal antibodies
    • Other Recombinant proteins, including cytokines
    • Vaccines
    • Tissue-engineered products

  • Medical and FDA Interactions

    We help you communicate effectively with FDA:

    • Meeting briefing documents
      • Type A, B, C, D, and INTERACT
    • Meeting strategy and rehearsals
    • Post-meeting follow-up and commitments

  • Regulatory Strategy

    We develop tailored regulatory strategies aligned with your product type, development stage, and commercial goals.

    • Regulatory pathway assessment (CDER vs. CBER)
    • Orphan Drug (OOPD)
    • Regenerative Medicine Advanced Therapies (RMAT)
    • Expedited Program Strategies
    • Global Regulatory Alignment
    • Endpoints including PKO’s
    • Dose Selection

  • Critical Submission

    • Responses to CR
    • Responses to 4831 warning letters
    • Responses to IRs

Key Services

Success With Critical GxP Services

Who We Are

Our team has 30 years of experience in regulatory affairs and are industry experts.

Submission Group

Our submissions group is seasoned and experienced in all aspects of document preparation and submissions. They apply their long and comprehensive experience with submission-ready templates, formatting, digital media, graphics, FDA guidelines, to the submission process. Their mastery of these guidelines and tools allow them to seamlessly enter the e-submission space without skipping a beat.

They have the current tools and methods but more importantly the knowledge and discipline to resolve even complex document preparation issues typically found in critical submission.

Get Started With the FDA

1

Request IND #

2

Submit Pre-IND Meeting Request and Briefing Book (4 Weeks)

3

FDA Pre-IND Type B Meeting (60 Days)

4

IND Submission (90 Days)

5

IND Lifecycle Management (Annual)

Are you ready to start your Phase I First in Human (FIH) Study?

Contact Us

Our expert team would love to help your company succeed. Don't wait for the moment — Make it!

Request a Consultation

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Are you ready for your FDA meeting and IND submission?

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