Clinical and Regulatory 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. We are experienced with all 505 pathways, establishment and product registrations, and DMFs.

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

Regulatory Strategy Built for Advanced Biotechnology

Emerging biotechnology companies face regulatory challenges that rarely fit a standard playbook. We provide focused regulatory affairs consulting to help pharmaceutical and biotech innovators advance complex therapies through development, submission, and FDA review with greater clarity, speed, and confidence.

What Sets Us Apart

Deep expertise in complex products

Our team has extensive experience supporting tissue-based products, peptides, large molecules, biologics, and drug-device combination products. We understand the scientific, procedural, and operational challenges that distinguish advanced therapies from conventional development programs.

Strategy backed by execution

We connect regulatory strategy directly to document preparation to submission operations. From product development planning and FDA meeting preparation to critical, time-sensitive filings, our clients work with one experienced team capable of moving from advice to action.

Proven FDA submission capabilities

Our in-house FDA submissions group provides strategic and operational support across ESG NextGen, CDER Direct, eSubmitter, eDRLS, and Structured Product Labeling submissions. We have completed more than 1,000 FDA submissions in the past few years.

Experienced FDA engagement

We help clients prepare for and navigate FDA interactions involving scientific, procedural, and product-development issues. Our support includes meeting strategy, briefing-package development, meeting preparation and representation, response planning, and resolution of review-related questions. We have filed over 100 INDs across every therapeutic area including specialties such as ophthalmology and medical imaging.

Quality embedded in every engagement

Our regulatory work is informed by extensive experience with Good Manufacturing Practice, Good Laboratory Practice, and Good Documentation Practice requirements. Our own GDP-based standard operating procedures govern document preparation, review, control, and submission management.

Responsive support when timing matters (24/7 Standing By)

Biotechnology programs often operate under compressed timelines, evolving data, and significant financing or development milestones. Our focused structure allows us to respond quickly while maintaining the rigor expected for submissions to CDER and CBER.

A Regulatory Partner for High-Stakes Development

We combine advanced-therapy expertise, hands-on FDA experience, disciplined submission operations, and responsive senior-level support. The result is a practical regulatory partnership designed to reduce execution risk and keep promising biotechnology programs moving forward.

Client files are exchanged and managed in accordance with the current cybersecurity and document-governance standards of the cloud services used for collaboration.

  • Regulatory Strategy for Advanced Biotechnologies

    Advanced therapies rarely follow a conventional development path. We help emerging biotechnology companies develop regulatory strategies grounded in the product’s science, manufacturing platform, clinical objectives, and business milestones, with support across tissue-based products, peptides, large molecules, biologics, and drug-device combination products from early development through marketing applications.

    We prepare sponsors for FDA interactions, develop briefing packages, provide meeting representation, and help resolve complex scientific and procedural issues. When appropriate, we also evaluate opportunities for earlier or more intensive FDA engagement through mechanisms such as INTERACT meetings, Fast Track, Breakthrough Therapy, Regenerative Medicine Advanced Therapy designation, and the START Pilot Program for qualifying rare-disease therapies, focusing on the regulatory pathway most likely to reduce uncertainty and advance a credible development program.

  • Integrated Product Manufacturing, and Quality Expertise

    For biotechnology companies, regulatory and manufacturing strategies are inseparable. We bring practical experience with Good Manufacturing Practice, Good Laboratory Practice, and Good Documentation Practice requirements to help clients anticipate quality and CMC issues that can delay development or undermine submissions, while supporting planning for innovative platforms, comparability strategies, analytical methods, process changes, technology transfers, and the transition from clinical to commercial production.

    When a technology may qualify, we help clients assess engagement opportunities through FDA initiatives such as CDER’s Emerging Technology Program, CBER’s Advanced Technologies Team, and the Advanced Manufacturing Technologies Designation Program, which can provide early dialogue with FDA on novel manufacturing methods, controls, and implementation strategies.

  • In-House FDA Submission Operations

    Unlike consulting firms that separate regulatory strategy from publishing and submission execution, we provide both capabilities through one coordinated team. Our in-house FDA submissions group supports ESG NextGen, FDA Direct/CDER Direct, eSubmitter, eDRLS, Structured Product Labeling, and other applicable FDA submission channels.

    With more than 1,000 FDA submissions completed in recent years, including critical and time-sensitive submissions to CDER and CBER, we help clients avoid preventable technical failures, manage acknowledgments and validation issues, maintain submission continuity, and navigate evolving requirements such as FDA’s transition to the cloud-based ESG NextGen Unified Submission Portal without diverting internal resources from product development.

  • Disciplined Document Management

    Biotechnology programs move quickly, but speed without document control creates risk. Our GDP-based standard operating procedures govern document preparation, review, approval, version control, and submission management, supporting traceability, inspection readiness, and consistent execution across the regulatory lifecycle.

    Client files are exchanged and managed in accordance with current cybersecurity and document-governance standards for the collaboration platforms in use. Clients also work directly with experienced regulatory professionals who understand the urgency of FDA meetings, clinical milestones, financing events, manufacturing changes, and regulatory deadlines, combining senior-level attention with the operational capacity to respond when timing is critical.

Key Services

Success With Critical GxP Services

Who We Are

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

Advisors

Submission Group

Our in-house Submission Group comprises seasoned regulatory writers, eCTD publishing professionals, document specialists, and quality assurance reviewers experienced in all aspects of document preparation and FDA submissions.

The team prepares and organizes content within the five-module eCTD structure: regional administrative information in Module 1; summaries and overviews in Module 2; quality and CMC information in Module 3; nonclinical reports in Module 4; and clinical information in Module 5. Using submission-ready templates and current publishing tools, our specialists manage formatting, metadata, hyperlinks, bookmarks, graphics, document granularity, sequence assembly, and technical validation.

Our writers and publishing professionals work closely with QA specialists to review each submission for accuracy, consistency, navigability, and technical compliance. They also manage eCTD lifecycle operations—including new sequences, amendments, replacements, and deletions—to maintain a clear and reliable regulatory record throughout product development.

More important than the tools themselves is the experience and discipline behind them. Our team can identify and resolve complex document-preparation and publishing issues often encountered in critical or time-sensitive submissions, helping clients move efficiently from final content to successful FDA transmission.

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 Compliant 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!

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