Drug Development & CMC Consulting

CMC and drug development consulting, from first formulation to approval

Specialist support across formulation, process, CDMO selection, regulatory CMC, Quality by Design, and preclinical GLP toxicology, for programs moving from early development through scale-up.

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6: CMC & development service areas
IND–NDA: regulatory CMC coverage
GLP: preclinical toxicology

One team across CMC and development

We help teams identify the development and CMC risks that matter, prioritize them, and build phase-appropriate plans that hold up through scale-up and regulatory review.

Formulation
Process
CDMO
Regulatory CMC
Strategy
Quality by Design
GLP Toxicology

Why PharWise

Our approach

Formulation development: laboratory characterization of an API

Grounded in development realities

We focus on what determines whether a program moves forward: how an API behaves, how a process scales, and what a reviewer will question. The result is practical guidance you can act on, not a catalogue of generic best practices.

Tailored development strategy and target analysis

Built around your molecule

No two APIs behave the same way. We design formulation, process, and CMC strategy around your specific molecule, indication, and stage of development, so the plan fits both the science and the business case behind it.

Coordinating a global network of contract manufacturing partners

One bottleneck or the whole program

Engage us to resolve a single bottleneck ahead of a deadline, or to run CMC alongside your team over the long term. We work to realistic timelines and adapt as the program evolves, so the engagement matches what you actually need.

How it works

How an engagement works

1
Initial call

A working session to understand where your program stands and the questions reviewers will raise.
2
Phase-appropriate plan

You receive a prioritized CMC and development plan: what to address now, what can wait, and what each step requires.
3
Execution alongside you

We work the plan with your team, through formulation, scale-up, and the regulatory CMC package submitted to the agency.

Consulting services

A complete toolkit for CMC and development

From first formulation to regulatory approval — one cohesive program, tailored to your molecule.

Formulation Development

Tailoring formulations to your unique needs

Developing a stable, effective formulation for your API can be complex. We bring a track record across a variety of APIs, including those hard to stabilize or solubilize, with a focus on phase-appropriate development, compliance, and robustness.

Pre-formulation — API characterization to select optimal components.
Dosage form selection — matched to API properties, indication, and market needs.
Comprehensive development — traditional and complex forms: semi-solids, suspensions, liquids, aerosols.
Lead optimization — performance, safety, shelf-life, and patient compliance.
Robustness — QbD principles to minimize formulation risk.

Process Development

Helping you scale up with confidence

Solving the complex challenges of process development and scale-up, from pilot phase through cGMP clinical manufacturing into commercialization, using QbD to de-risk scale-up and meet quality and regulatory standards.

Evaluation & optimization — troubleshooting to minimize production risk.
Documentation review — compliance review and gap analysis.
CMO selection & tech transfer — global network, efficient transfer.
Scale-up — pilot to commercial scale on time.
QbD de-risking — risk reduction and regulatory compliance.

CDMO Management

Partnering for seamless drug outsourcing

CDMO search and management to keep your clinical trials and production running smoothly, with a large network across drug substance and drug product manufacturers, plus technical consulting and project management.

Search & selection — the right CMO/CRO for clinical and commercial supply.
Contract negotiation — best terms on pricing, timelines, and quality.
Ongoing management — end-to-end CMC project oversight.
Risk mitigation — supply chain, quality, and compliance.
Production planning — schedules, inventory, and timelines.

Regulatory CMC

Accelerating your product’s regulatory journey

A hands-on approach to regulatory submissions, authoring CMC documents and supporting regulatory meetings. Track record of timely submissions, successful FDA interactions, and NDA approvals across preclinical through post-approval.

Strategic planning — roadmap with timelines, budget, and expectations.
CMC gap analysis — remediation to avoid costly delays.
CMC documentation — prepared and reviewed for IND/NDA.
FDA interactions — Pre-IND, EOP2, and CMC questions.

Development Strategy

Tailored strategies to meet your goals

A clear strategy addresses the scientific, regulatory, and quality challenges of drug development. We analyze the landscape and focus on planning, risk management, and proactive decisions to bring your product to market.

Development plans — timelines, milestones, budgets, risk plan.
Project management — early stage through submission and approval.
Outsourcing strategy — successful execution at lower cost.
Supply chain — lower cost, less risk, on-time delivery.
Due diligence — in- and out-licensing support.

Quality by Design

A proactive approach to drug development

The FDA encourages QbD components in submissions. We help you understand and implement QbD while accelerating speed to market, launching safe, effective products reliably through a scientifically sound, compliant approach.

Risk assessments — product and process risk with mitigation.
QbD elements — defining CQAs, CMAs, and CPPs.
Design of Experiments — identifying critical parameters.
Knowledge & design space — ranges for consistent quality.
Control strategy — process controls and acceptance criteria.