Regulatory / CMC

Accelerate Your Path to Market with Confidence.

Our team of experienced regulatory professionals provides end-to-end regulatory and CMC support, guiding products from preclinical development through commercialization and lifecycle management. We partner with organizations across the pharmaceutical, biotechnology, medical device, and consumer health sectors to navigate complex regulatory requirements while keeping development programs efficient, compliant, and scalable.

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End-to-End Support

Pharmaceutical · Biotechnology · Medical Device · Consumer Health

How we help

Complex requirements.
Clear direction.

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Global Regulatory Strategy / Asset Due Diligence

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Advice and assistance on regulatory filings
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Regulatory risk assessment & risk mitigation plans
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Due diligence for strategic acquisitions & mergers
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Evaluation & resolution of regulatory compliance issues

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Lead Regulatory Authority Meetings

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US and Canadian regulatory representation;
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Pre-submission meetings & briefing packages;
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Pre-IND meetings;
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FDA Type A/B/C meetings

Regulatory Dossier Preparation, Review and Submissions

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Chemistry, manufacturing and Controls (CMC) writing;
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Marketing Application Support USA ( NDA, BLA, ANDA, 510(k), PMA etc.) Canada (NDS, DIN, NHP, PLA etc.); Investigations; New Drug (IND); Clinical Trials Application (CTA);
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Establilshment/Site Approval Licence Application Support; Post approval and lifecycle management

Pre-Approval Inspection & Regulatory Audit Inspection Readiness & Training

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Regulatory Inspection Readiness support (Health Canada, FDA, NIH, MHRA, EMA)
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Mock Regulatory Inspections
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On-Site support during Regulatory Inspections; Responses to FDA 483s & warning letters; Assistance and SME consulting to legal counsel in FDA enforcement matters

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Labelling Compliance and Virtual / Fractional Regulatory Affairs Support

Support Worldwide

Global reach

Across the Product Lifecycle

Regulatory agencies

N
Health Canada
N
U.S. Food and Drug Administration (FDA)
N
European Medicines Agency (EMA)
N
Medicines and Healthcare products Regulatory Agency (MHRA)
N
National Institutes of Health (NIH) and other regulatory stakeholders

Pathways & applications

N
INDs (Investigational New Drug Applications)
N
CTAs (Clinical Trial Applications)
N
NDAs (New Drug Applications)
N
BLAs (Biologics License Applications)
N
ANDAs (Abbreviated New Drug Applications)
N
510(k) and PMA submissions
N
NDS, DIN, and Drug Establishment Licensing
N
NHP and PLA applications
N
Post-market amendments, supplements, and renewals

Across the product lifecycle

From first strategy to
long-term growth.

01 Pre-Clinical Development

02 Clinical Development

03 Regulatory Submission

04 Approval & Launch

05 Lifecycle Management

Relevant Experience

Helping actual, clients.

Representative examples of the strategic and practical support our regulatory professionals provide. Add your next project to our list, start by booking your free 30 minute consultation.

Representative Engagement 02

Regulatory Strategy & Submission

Our team developed the submission pathway, coordinated documentation and supported authority interactions.

Outcome

CLEAR, SUBMISSION-READY PROGRAM

Representative Engagement 01

FDA Product Approval Support

We assisted a client in navigating FDA requirements and securing approval of a new product.

Outcome

90-day path to market

Regulatory experts reviewing a submission dossier

Targeted Focus

Industries
we support.

Whether you require a fully managed regulatory submission, a fractional or interim Regulatory Affairs leader, or resource augmentation to strengthen your internal team, we offer flexible engagement models tailored to your organization's needs.

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Small molecules
N
Antibody-drug conjugates (ADCs)
N
Vaccines
N
Medical devices
N
Natural Health Products (NHPs)

N
Biologics
N
Blood and plasma products
N
Cell and gene therapies
N
Controlled substances
N
Cosmetics

Flexible engagement models

01

Fully managed regulatory submission

02

Fractional or interim Regulatory Affairs leader

03

Resource augmentation for your internal team

Strategic expertise

From first strategy to
long-term growth.

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Regulatory and CMC strategy development
N
Product labeling and compliance reviews
N
Post-approval submissions and lifecycle management

N
Health authority interactions and meeting support
N
Market authorization planning and execution
N
Regulatory intelligence and risk assessment

A smarter approach

Regulatory success is about more than compliance.

It is about building a strategy that supports long-term growth. We combine deep regulatory expertise with practical execution to reduce risk, streamline development timelines and bring innovative products to market efficiently.

From early development to commercialization and beyond, we provide the expertise, flexibility and strategic guidance needed to move your product forward with confidence.

Broader Scope

Other services.

Clinical Trial Support

Learn More

Quality & Compliance Services

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Let's talk

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