Services & Packages

Regulatory services across the full drug development lifecycle.

From first IND to post-approval, every service area is handled by one experienced point of contact, with engagement models built around your team.

What I Do

Core service areas.

Initial Clinical Trial Applications (IND)

Organizing, compiling, and submitting Initial Investigational New Drug applications in accordance with FDA and international requirements. End-to-end ownership from strategy through submission.

FDA

EMA

ECTD

Initial New Drug Applications (NDA) in eCTD Format

Filing complete NDAs in electronic Common Technical Document format. Structuring, reviewing, and finalizing submission packages that meet agency expectations and reduce review cycle time.

NDA

ECTD

FDA

Clinical Study Reports & Investigator Brochures

Compiling Final Clinical Study Reports, Investigator Brochures, and supporting regulatory documents to ICH E3 and E6 standards.

ICH E3

ICH E6

CSR

Clinical Protocols & Briefing Packages

Drafting, reviewing, and formatting clinical protocols and regulatory briefing documents for pre-IND, Type A/B/C meetings, and advisory committee interactions.

PRE=IND

Type A/B/C

Advisory

New Drug & Biological License Applications (NDA/BLA)

Full submission management for NDAs and BLAs — from gap analysis and module authoring through agency correspondence and deficiency responses.

NDA

BLA

Module Authoring

Post-Approval Submission Support

Supplemental NDA/BLA filings, CBE-0 and CBE-30 submissions, annual reports, and labeling updates following initial approval.

CBE-0

CBE-30

Labeling

Vendor Oversight & Project Management

Oversight of CROs, CMOs, and regulatory service vendors on behalf of sponsors. Ensuring timelines, quality standards, and regulatory commitments are met across the supply chain.

CRO

CMO

Oversight

Regulatory Information Management (RIMS)

Setup, maintenance, and optimization of RIMS platforms to track submissions, agency interactions, product registrations, and regulatory intelligence across global markets.

RIMS

Global

Intelligence

Global Reach

Regulatory expertise across five continents.

With nearly three decades of experience navigating agencies across the US, Europe, South America, Australia, and Africa, KKW brings practical knowledge of regional requirements — not just familiarity with the guidelines.

Discovery Call

21 CFR, IND / NDA / BLA

EMA (Europe)

CHMP, IMPD, MAA

South America

ANVISA, ANMAT, ISP

Australia (TGA)

CTN, ARTG, CER

Africa

SAHPRA, NAFDAC

Engagement Models

Built around how you actually need help.

Three models, one point of contact. Choose the level of engagement that fits your team size, timeline, and deliverable.

Hourly

Project Support

Teams that need targeted, short-term regulatory expertise on a specific task or filing.

Force Multiplier

Embedded Regulatory Partner

Teams that need ongoing hands-on support without hiring full-time staff.

Fixed Scope

Full-Service Regulatory Management

Organizations that want end-to-end ownership of a filing or program.

At a Glance

Compare engagement models.

	Project Support	Embedded Regulatory Partner	Full-Service Regulatory Management
Best for	Single tasks / short scope	Ongoing team support	End-to-end program ownership
Billing	Hourly	Retainer / recurring hours	Fixed fee
Commitment	None	Flexible	Project-scoped
Project management	Client-led	Shared	KKW-led
Audit support	—	As needed	✓ Included

Not sure which model fits your project? Most clients start with a discovery call and we scope the right engagement together — often a hybrid of two models.