Regulatory Affairs Consulting

Whether you are preparing an IND for a first-in-human trial, responding to agency questions mid-review, or managing regulatory workload across multiple programs without a full-time regulatory lead, the work requires people who have done it before and understand what agencies expect.

Alacrita provides regulatory affairs consulting from preclinical strategy through marketing authorization: regulatory feasibility, pathway strategy, hands-on submission preparation, agency interactions, and interim regulatory leadership. Our consultants include former agency staff and experienced industry regulatory professionals with direct FDA and EMA submission experience across small molecules, biologics, cell therapies, gene therapies, peptides, microbiome therapeutics, and other modalities.

Regulatory Affairs Overview

The drug development pathway and where we engage

IND NDA / BLA / 505(b)(2) Preclinical Phase 1 Phase 2 Phase 3 FDA Review IND-enabling tox & CMC First-in-human safety POC, dose finding Pivotal efficacy 6 to 10 months
Strategy & IND preparation
  • Pathway feasibility and regulatory strategy
  • IND-enabling planning
  • Pre-IND briefing book and FDA meeting
  • IND assembly, regulatory writing, eCTD publishing
Designations & CMC regulatory
  • Orphan Drug Designation
  • Fast Track
  • CMC regulatory support
  • End-of-Phase 1 meeting
Scientific advice & expedited pathways
  • Scientific advice
  • Breakthrough Therapy
  • PRIME (EMA)
  • End-of-Phase 2 meeting
Pivotal regulatory & submission prep
  • Phase 3 design strategy
  • EAMS, Accelerated Approval, Conditional Approval
  • Pre-NDA meeting preparation
  • NDA, BLA, or 505(b)(2) assembly and regulatory writing
Review response & labeling
  • Response strategy for agency questions
  • Briefing book updates
  • Advisory committee preparation
  • Labeling refinement

Core Areas of Expertise

The first six practices align with the development stages shown above. The last two apply across stages.

Regulatory Strategy & Pathway Assessment: Evaluating your program's regulatory position: chosen pathway, timeline assumptions, outstanding data requirements, and whether expedited pathways are viable for your product and indication.
Pre-IND & Scientific Advice Preparation: Developing briefing documents, structuring agency questions, rehearsing responses, and attending meetings with you. Covers FDA pre-IND meetings, EMA scientific advice, and MHRA interactions.
IND/CTA Preparation & Submission: Hands-on preparation of IND and CTA packages: gap analysis, document assembly, regulatory writing, and eCTD compilation and publishing. From high-level review through full submission management. Alacrita maintains relationships with specialist eCTD publishing partners.
CMC Regulatory Strategy: Regulatory strategy for chemistry, manufacturing, and controls: CMC sections of submissions, comparability protocols for process changes, manufacturing site transfers, and coordination between CMC development and regulatory requirements.
Expedited Pathway & Designation Applications: Preparing and submitting applications for Orphan Drug Designation, Breakthrough Therapy, Fast Track, PRIME, EAMS, RMAT, Accelerated Approval, and Conditional Approval. Includes appeals of initial agency refusals and Paediatric Investigation Plans (PIPs).
BLA/NDA/MAA Submission Support: Late-stage submission preparation for marketing authorization across FDA, EMA, and other jurisdictions. Includes dossier review, regulatory writing (CSRs, summaries of efficacy and safety, clinical overviews), and labeling.
 
Specialized Regulatory Pathways: Strategy for biosimilar and generic regulatory filings, 505(b)(2) applications, drug repurposing, and Well-Established Use pathways in the EU.
Regulatory Due Diligence: Risk assessment for investors, in-licensors, and acquirers covering pathway viability, agency correspondence, red flags, and timelines. Findings feed into valuation, milestone structure, and reps & warranties; conflict screening is standard. See our Due Diligence page for the full practice.

Engagement Models

Engagements take one of three structures, depending on the depth of involvement required.

Regulatory Strategy Projects

Project-based engagements with defined scope and deliverables. Alacrita provides analysis and recommendations; your team decides how to act on them.

  • Regulatory feasibility assessment before fundraising
  • Pathway analysis for a novel modality
  • Gap analysis before an IND filing
  • Regulatory due diligence for investment or in-licensing

Hands-On Submission Support

Consultants work alongside or in place of your regulatory team on specific submissions. Scope ranges from document review and gap analysis to fully preparing and managing the submission.

  • IND/CTA packages
  • Designation applications (ODD, Fast Track, Breakthrough, PRIME, EAMS)
  • Briefing documents and pre-meeting preparation
  • eCTD compilation and publishing
  • Responses to agency questions and information requests

Interim Regulatory Leadership

Experienced VP Regulatory or Head of Regulatory professionals embedded in your organization on an interim or fractional basis. See the dedicated section below for detail.

  • Pre-submission and pre-IND periods
  • Leadership transitions or VP Regulatory departures
  • Scaling from one program to several
  • Virtual or semi-virtual biotechs needing senior regulatory without a full-time hire

Interim Regulatory Leadership

The third engagement model above, interim regulatory leadership, is the deepest of the three. The detail below covers what it includes and when companies engage it.

Programs reaching IND-enabling studies, managing multiple active submissions, or scaling from one program to several often need a regulatory leader before they can justify or recruit a permanent hire. An interim or fractional VP Regulatory provides that leadership without the timeline or commitment of a full-time search. Consultants come from Alacrita's network of senior regulatory professionals with prior VP Regulatory or Head of Regulatory experience.

What an Interim VP Regulatory Does

Owns the regulatory strategy across programs and acts as the primary agency contact
Manages IND, CTA, and marketing application timelines and submissions
Coordinates CMC, clinical, and preclinical inputs into regulatory documents
Leads preparation for agency meetings and responses to information requests
Builds or restructures the regulatory function for long-term sustainability
Represents the regulatory perspective in board and investor discussions

Interim

Defined endpoint. Through IND submission, through a regulatory milestone, or until a permanent hire is onboarded. Full-time or near-full-time commitment for the duration.

Fractional

Ongoing part-time engagement. Two or three days per week providing regulatory oversight across programs, attending key meetings, and managing agency interactions on an ongoing basis.

Recent Engagements

A selection of recent engagements, grouped by type of work.

Pre-IND meetings and scientific advice preparation

FDA pre-IND meeting for an oral form of an approved biologic in endocrine disorders. Pre-IND preparation and gap analysis for a small molecule in metabolic disease. FDA pre-IND for a microbiome therapeutic in infectious disease. Documentation gap analysis ahead of an FDA scientific advice meeting for a CNS cell therapy. MHRA scientific advice for a Phase II monoclonal antibody trial in primary sclerosing cholangitis.

IND and CTA submission preparation

CTA submission support for a monoclonal antibody in primary sclerosing cholangitis. CTA submission support for an oral biologic in endocrine disorders, followed by preparation of a US IND from the existing EU CTA. Gap analysis for a UK CTA submission for a novel iron therapy in iron-deficiency anemia. AAV gene therapy preclinical, CMC, and regulatory strategy at IND-enabling stage.

Orphan Drug Designation applications and appeals

EU Orphan Drug Designation for a gene therapy in retinitis pigmentosa. EU Orphan Drug Designation for an oral peptide therapeutic in endocrine disorders. Successful appeal of an FDA refusal of orphan drug designation for a CAR-T therapy.

Expedited access and paediatric program applications

EMA PRIME status for an oncolytic virus in pediatric brain cancer. MHRA Early Access to Medicines Scheme (EAMS) for the same program. EU Paediatric Investigation Plan (PIP) for the same program.

Marketing authorization preparation and response strategy

BLA process review and CMC dossier sign-off for a novel antibody therapeutic completing Phase III in oncology. International registration support for an oncology small molecule in renal cell carcinoma and hepatocellular carcinoma. Regulatory strategy for a generic version of a major anti-diabetic peptide. Regulatory analysis and response strategy following a rejected EU marketing authorization for a generic peptide.

Cell and gene therapy regulatory and CMC strategy

FDA regulatory affairs consulting for a first-in-class allogeneic NK cell therapy. Regulatory strategy for a TCR-based T-cell therapy. Cell and gene therapy regulatory support for a publicly-traded biotech with programs in HIV and oncology. CMC and regulatory support for an AAV-based in vivo gene therapy program at IND-enabling stage.

Novel platform regulatory strategy and drug repurposing

Regulatory plan for a novel intracellular delivery platform across multiple therapeutic uses. Regulatory plan for a nanotechnology drug delivery platform in oncology. FDA support for a repurposed small molecule in ischemic stroke. Regulatory strategy for an ophthalmology product based on repurposing of an established drug class. Regulatory strategy for a small molecule candidate in fibrotic disease.

Regulatory due diligence for investment and licensing decisions

Regulatory due diligence on an atrial fibrillation small molecule for a venture investor. Due diligence on a chemotherapy-induced anemia program. Assessment of a pluripotent stem cell platform for an institutional investor. Distressed company analysis for an asset-scouting engagement.

Medical device regulatory submissions and quality audits

ISO 13485 audit of a manufacturing site for a healthcare consumer products company. 510(k) submission support for a novel lung function device. Regulatory pathway mapping for advanced wound care products. Regulatory approval advice for a genetic ancestry DNA device.

Regulatory Affairs Case Studies

For full detail on selected engagements, the case studies below cover specific situations in depth.

Regulatory Affairs

Gene therapy preclinical, CMC, & regulatory strategy

Challenge: An early-stage biotechnology startup company reached out to Alacrita for critical support of its two lead AAV-delivered gene therapy programs. As a virtual company, the...
Read full case study
 Regulatory Affairs

Regulatory support to understand likelihood of approval of an ophthalmology asset

Challenge: A European pharmaceutical company focussed on ophthalmic care was seeking Well Established Use (WEU) approval in Europe for a small molecule asset. The company...
Read full case study
 Regulatory Affairs

Regulatory analysis of rejected marketing authorization & response strategy

Challenge: Our client, a major generics and biosimilars player, was developing a generic version of a major therapeutic. It had submitted a dossier for marketing authorization in...
Read full case study
 Regulatory Affairs

Preparing a EU Paediatric Investigators Plan

Challenge: Our client was developing oncolytic viruses for treating a rare form of brain cancer. Its lead product had been successfully evaluated in a Phase I dose-escalation...
Read full case study
View All Regulatory Affairs Case Studies

Frequently Asked Questions

What types of regulatory support does Alacrita provide?

+

Does Alacrita do regulatory strategy only, or also hands-on submission preparation?

+

Both. Alacrita does regulatory strategy work (pathway assessment, gap analysis, scientific advice preparation, due diligence), and the majority of engagements involve hands-on submission preparation: document authoring, IND/CTA assembly, eCTD compilation, agency response drafting, and BLA/MAA support. Many engagements begin with strategic assessment and continue into execution of the resulting plan.

Alacrita provides regulatory consulting from preclinical through marketing authorization: regulatory strategy and pathway assessment, IND/CTA/BLA/NDA/MAA preparation and submission, expedited pathway and designation applications (Orphan Drug, Breakthrough Therapy, Fast Track, PRIME, EAMS, RMAT), eCTD publishing, CMC regulatory strategy, pre-IND and scientific advice preparation, regulatory due diligence, regulatory writing, biosimilar and generic regulatory strategy, drug repurposing pathways, and interim regulatory leadership.

Can you support FDA, EMA, and other global regulatory pathways?

+

Can Alacrita handle the full submission lifecycle, or only specific stages?

+

How does Alacrita differ from large regulatory CROs (Parexel, IQVIA, ICON)?

+

Large regulatory CROs operate at scale with standardized processes designed for ongoing pharma volume. Alacrita's model is different: senior-only consultants with hands-on submission experience, matched to the specific therapeutic area and modality, with engagement scope sized to the work. For early-stage and mid-size biotechs, this means working directly with people who have submitted IND/BLA packages and held regulatory leadership roles, rather than being routed through a process designed for larger volume. For larger pharma clients, Alacrita supplements internal regulatory teams on specialized work where the senior depth and modality-specific match are the value.

Both. Engagements range from single-stage support (preparing a designation application, drafting a briefing document, eCTD publishing of one section) to multi-year programs taking an asset from preclinical regulatory strategy through IND, clinical-stage submissions, and BLA/MAA filing. The model accommodates either: discrete projects where Alacrita delivers a specific work product, or extended programs where regulatory leadership continues across stages.

Yes. FDA and EMA work is the core of the practice, with many consultants experienced across both agencies. MHRA work appears regularly, and we have consultants with experience in other regional regulatory pathways as needed. For programs pursuing parallel US and EU development, we coordinate strategy across both pathways, including simultaneous preparation for FDA pre-IND meetings and EMA scientific advice. We have supported clients through IND and CTA submissions, orphan drug designations in both jurisdictions, and dual BLA/MAA filings.

What does hands-on submission support include?

+

Does Alacrita have former FDA or EMA staff?

+

Yes. The regulatory affairs network includes consultants with direct prior experience at FDA, EMA, and MHRA, alongside consultants whose careers have been on the industry side preparing and defending submissions. For engagements requiring former-agency perspective (advisory committee preparation, complex pathway questions, agency dispute strategy), Alacrita matches consultants with the relevant background.

It ranges from gap analysis and document review to Alacrita fully preparing and managing the submission. For IND/CTA packages, that includes assembling preclinical, CMC, and clinical sections, writing regulatory documents, coordinating inputs from your development team, and eCTD compilation and publishing. Alacrita maintains relationships with specialist eCTD publishing partners and has consultants experienced in eCTD preparation.

How quickly can you provide regulatory support for an urgent submission?

+

For most engagements, Alacrita identifies the right consultant and begins work within one to two weeks. When the right match is already known and has capacity, faster turns are possible. The depth of the network (99+ regulatory affairs consultants across 22 disease areas and 18 product modalities) means we're rarely starting from scratch on a given therapeutic category or regulatory pathway.

How do your regulatory consultants differ from those at staffing agencies?

+

Alacrita manages the engagement, the consultants, and the work product. Whether the deliverable is a regulatory strategy document, a complete IND package, or interim regulatory leadership embedded in your organization, Alacrita is responsible for the outcome and stays accountable from start to finish. Consultants are managed by Alacrita, not introduced and left for you to coordinate.

Do you support medical device regulatory submissions?

+

We have consultants with device regulatory experience, including CE marking, 510(k) submissions, and ISO 13485 quality system audits. Device regulatory work is a smaller part of our practice; our primary focus is therapeutics including small molecules, biologics, cell therapies, gene therapies, and other advanced therapy medicinal products.

Can engagements be project-based, or are they only ongoing leadership roles?

+

Both. Alacrita engages on discrete projects (submissions, designations, gap analyses, regulatory due diligence, response strategies) and on interim regulatory leadership for programs that need ongoing functional coverage. Many engagements start as specific projects and expand into broader support.

Get in Touch

Reach out to discuss your regulatory affairs needs.

Contact Us

Reach out today for more information on regulatory affairs expertise.