Kinetic CMC Consulting Limited · Auckland, NZ
FDA CMC Regulatory Affairs · Contract & Fractional Support for US Pharma

CMC regulatory affairs support, delivered without the ramp-up time

Kinetic CMC Consulting Ltd provides subcontract and fractional CMC regulatory writing and review capacity for pharma companies and consulting firms — ANDAs, NDAs, and post-approval submissions, backed by 24 years of regulatory affairs leadership.

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24 yrs CMC regulatory affairs (US & EU) NZ‑registered entity, US‑ready contracting 2 first-cycle ANDA approvals Delivery across US, EU, AU & NZ
US · New York Empire State Building, New York
NZ · Auckland Auckland skyline at dusk
Global delivery, one point of contact
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Capabilities

Full-pipeline CMC regulatory support — from source lab data to a first-cycle-approved dossier, without handing the work between specialists.

Narrative

Regulatory storytelling

Source documents and lab data turned into clear, defensible regulatory narrative using ICH and agency guidelines as the framework.

Ownership

End-to-end submissions

ANDAs, 505(b)(2) NDAs, Generic MAAs (EU), deficiency responses, and the full post-approval lifecycle.

Compliance

High-friction compliance

Extractables & leachables, ICH Q3D elemental impurities, USP <661.1>/<661.2>, and drug-device threshold analysis.

Infrastructure

Templates & process

eCTD Module 2/3 templates and formatting standards built from scratch and adopted company-wide, with 100+ staff trained.

Emerging

Biosimilar & emerging modalities

Regulatory lead experience through an FDA Biosimilar Initial Advisory (BIA) meeting package — a working foundation, scoped honestly.

Delivery

Cross-timezone delivery

A multi-year operating record collaborating with US teams from New Zealand — a head start on the day, not a gap.

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Contracting for US clients — 3 simple steps

Kinetic CMC Consulting Ltd is a New Zealand entity. The contract, tax form, and payment sequence for US client work is straightforward.

1

Client signs with Kinetic

The services agreement names Kinetic CMC Consulting Ltd as the contracting party.

2

Kinetic provides a W‑8BEN‑E

As a foreign entity, Kinetic provides a W‑8BEN‑E rather than a W‑9 — certifying “Active NFFE” status.

3

Client pays Kinetic in USD

Funds go to a Kinetic‑held US bank account (Wise Business), matching the entity named on the contract and the W‑8BEN‑E.

These steps ensure that US and NZ tax obligations can be met with a clear audit trail.

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Credentials & coverage

EducationB.S., Biochemistry (Indiana University); M.A. program, Statistics (Columbia University)
Experience24 years in regulatory affairs, of 30+ total in the pharmaceutical industry
CertificationRAC‑US, RAPS (2019, 99th percentile score)
CitizenshipDual, on staff — US and New Zealand

Covered by professional (errors & omissions) indemnity insurance, with coverage extending to US‑based engagements — a certificate is available upon engagement.

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Leadership

Suzett L. Perry
Suzett L. Perry
RAC‑US · Director, Kinetic CMC Consulting Limited

Twenty-four years in CMC regulatory affairs, including remote leadership of US product regulatory activities across ANDAs, NDAs, and post-approval submissions. Full pipeline experience — bench science, scientific writing, and regulatory affairs — means every engagement is led personally, not delegated to a junior team.

More about Suzett →
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Who this is for

Regulatory consulting firms

Needing subcontract CMC writing and review capacity they can deploy against client work without ramp-up time.

Small-to-mid pharma & generics companies

Too small for a full-time Regulatory Affairs Manager, but needing senior CMC regulatory writing and review leadership on a fractional basis.

Companies facing a specific compliance project

Extractables & leachables, elemental impurities, drug-device threshold analysis, or early biosimilar development.

Pharmaceutical staffing agencies & recruiters

Placing a CMC regulatory writer on a contract role, with a candidate who already carries her own liability coverage, US-ready contracting entity, and 24 years of directly relevant submission experience.

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Questions we get asked

What does a CMC regulatory affairs consultant do?

Writes, reviews, and manages the technical documentation that supports a drug product's approval and post-approval lifecycle with health authorities like the FDA.

Does Kinetic prepare ANDAs and NDAs?

Yes — 24 years of experience preparing ANDAs, 505(b)(2) NDAs, Generic MAAs for the EU, and full post-approval submissions, including first-cycle ANDA approvals.

Can Kinetic support extractables & leachables or elemental impurities projects?

Yes — including leading a multi-site extractables & leachables project team and award-winning ICH Q3D elemental impurities work.

Does Kinetic have biosimilar or biologic experience?

A working foundation through an FDA Biosimilar Initial Advisory (BIA) meeting package, scoped honestly against each client's need.

How does contracting work for US clients?

Kinetic CMC Consulting Ltd is a New Zealand entity, so US clients sign with Kinetic, request a W‑8BEN‑E, and pay in USD to a Kinetic‑held US bank account (Wise Business).

What engagement models does Kinetic offer?

Flexible arrangements from a few hours a week to full-time support, and from short-term to longer engagements.

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Get in touch

Tell us about the CMC regulatory work you need supported — a single submission, an ongoing fractional arrangement, or a specific compliance project — and we'll get back to you directly.

Direct
suzett.perry@gmail.com