IND/IMPD Support

Work with subject matter experts to successfully submit your IND/IMPD.

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CMC Support

IND & IMPD: A Guide to your clinical trial application

As an experienced CDMO, we know that drug discovery and development is a complex process. Throughout the drug discovery pathway, discovery encompasses a series of scientific, regulatory, and commercial activities aimed at discovering and bringing safe and effective medicines to the market. A key milestone in this process is candidate selection when a decision is taken to invest in a single molecule and transition the program from discovery into development. This transition prompts a number of activities to facilitate drug development, one of which is an assessment of potential sources of issues or delays in subsequent development.  Upperton’s path to IND & IMPD navigates this challenging pathway route head on, supporting biotechs with clarity as they begin their journey into clinical trials. 

Our model is built around:

  • One-site delivery for seamless project execution
  • Embedded senior leadership on every project
  • Scalable science that evolves with your programme
  • Flexible, responsive partnerships tailored to biotech needs

When you are ready to begin your CDMO journey, Upperton specialises in:

Inhalation drug products (pulmonary delivery)
Oral solid dosage form tablets and capsules
Oral solid dosage forms (OSD)
Nasal drug delivery systems
Parenteral formulations

CMC Support

An Efficient and Reliable Process For Your Drug Product Packaging and Labelling Need

An Investigational Medicinal Product Dossier (IMPD) contains essential data on the quality, production and control of the medicinal product being researched. Partnering with an experienced CDMO can significantly strengthen your ability to create and submit a successful IND/IMPD.

At Upperton, our goal is to support clients through the successful submission of their IND/IMPD, providing tailored support to meet the specific requirements of each project. Our support can include:

  • Robust Documentation Planning We bring extensive CDMO experience to the planning and preparation of essential documentation. This includes mapping documentation requirements, implementing quality control measures, validating methods and tailoring manufacturing processes to the specific needs of your project.
  • Proactive Regulatory Planning Our regulatory experts are integrated from the outset to develop a clear understanding of your regulatory requirements. We identify potential challenges early, conduct thorough risk assessments and develop targeted mitigation strategies to help ensure a smooth approval process.
Discuss your individual project requirements

IND or IMPD — We Can Support Both

Whether your regulatory pathway is in the USA or European Union, our expertise can support your development programme.

IND (Investigational New Drug Application)

Required in the USA before a new drug can be tested in human clinical trials. The IND application must contain detailed information about the study protocol, the chemical and pharmaceutical properties of the drug as well as data from animal studies to ensure the safety of the drug for use in humans.

IMPD (Investigational Medicinal Product Dossier)

Required in the European Union before a new drug can be tested in clinical trials. The IMPD contains comprehensive information on the investigational medicinal product, including chemical, pharmaceutical, toxicological and clinical data, as well as information on manufacturing and quality control.

Why Upperton

At Upperton, we specialise in the formulation and development of complex molecules, supporting a wide range of advanced drug delivery systems.

Our expertise spans:

By combining scientific excellence with practical development expertise, we help overcome the challenges of complex drug products and accelerate their path to clinic and market.

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partnership

Why Partner with Upperton

We provide fully integrated services across every stage of drug product development:

Microscope and analysis equipment at the Upperton facility

One Site

Integrated, end-to-end capabilities delivered under one roof.

Upperton scientist examining a formulation flask

One Team

The same team from your early-stage development through to preparation for commercial launch.

Test tubes used in complex molecule formulation development

Complex Molecule Expertise:

Proven track record in solving formulation and delivery challenges.

Upperton senior leadership overseeing laboratory work

Executive Leadership on Every Project:

Direct access to experienced senior leadership for strategic oversight and decision-making.

Got questions around IND and IMPD?

Speak to our SME team about your project.

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IND/IMPD FAQs

Yes. Upperton provides CMC data packages, manufacturing documentation, and pharmaceutical development reports compatible with both FDA and EMA expectations. We work closely with clients to ensure that the required technical content aligns with regional regulatory pathways. 

We generate a full suite of CMC materials including: Drug Product/Drug Substance characterisation Formulation development data Manufacturing process descriptions Analytical methods and validation data Specifications and stability studies 

The earlier the better. Partnering from preclinical or early formulation stages allows us to optimise your development strategy, generate high‑quality data, and avoid delays during IND/IMPD preparation. 

Absolutely. While we don’t act as your regulatory agent, we collaborate closely with regulatory consultants and ensure all CMC content is submission‑ready. We also provide scientific justification, risk assessments, and responses to regulator questions as needed.  

Yes. Upperton can support non‑GMP, GMP, and Phase I/II clinical manufacturing at our Trent Gateway CDMO facility, enabling a smooth transition from development into clinical supply. 

Timelines depend on project complexity and data availability. Typically, a CMC package can be generated within a few weeks to a few months. We provide clear timelines at project initiation and maintain transparent communication throughout. 

Timelines depend on project complexity and data availability. Typically, a CMC package can be generated within a few weeks to a few months. We provide clear timelines at project initiation and maintain transparent communication throughout. 

Yes. We frequently work with projects that require CMC remediation, reverse‑engineering of missing data, or strengthening of existing documentation to meet current regulatory expectations. 

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We provide fully integrated services across every stage of drug product development.

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