Expert Medical & Regulatory Affairs Consultants

Supporting innovators from early development through approval with deep expertise in CDER and CBER

Laboratory equipment used in pharmaceutical regulatory compliance

Overview

Overview

We are a highly focused regulatory affairs consulting group dedicated to supporting pharmaceutical, and emerging biotechnology, companies advanced therapies by navigating complex regulatory pathways. With deep experience in Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Documentation Practice (GDP) with our in-house FDA submissions, we provide strategic and operational support across a product's life-cycle.

Our team has extensive experience working with the FDA, including FDA meeting preparation and representation, development strategy, key submissions to CDER and tissue-based products, peptides, large molecules and novel biologics.

Our document and submission management processes are governed by our own GDP SOPs. File exchange with clients is under current cybersecurity and document governance standards.

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 phases of development. Early-stage guidance compliant manufacturing, pharm-tox and translation and FIH studies, supporting with full regulatory and GxP needs.

  • Therapeutic Focus

    • Cell and gene therapies
    • Monoclonal antibodies
    • Recombinant proteins
    • Vaccines
    • Tissue-engineered products

  • Medical and FDA Interactions

    We help you communicate effectively with FDA:

    • Meeting briefing documents
    • 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
    • Dose Selection

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

Fill out our contact form and one of our experts will reach out to you shortly.

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Are you ready for your FDA meeting and IND submission?

One decision changes everything.