Controlled Substance Development and Manufacturing

Supporting Drug Products Containing Controlled Substances.

Developing medicines containing controlled substances requires specialist expertise, robust quality systems, and a development partner that understands the regulatory complexities involved. At Upperton, we support pharmaceutical and biotechnology companies with the formulation development, clinical manufacturing, and scale-up of drug products containing controlled substances, helping programmes progress efficiently from early development through to commercial readiness.

Our integrated development and manufacturing teams provide a seamless pathway for controlled substance projects, combining scientific expertise with regulatory compliance and secure handling processes to support successful product development.

Supporting the Development of Controlled Drug Products

As innovative therapies continue to emerge across areas such as central nervous system (CNS) disorders, pain management, addiction treatment, and rare diseases, many developers require specialist support for products containing scheduled or regulated compounds.Upperton has the expertise, facilities, and quality systems required to work with controlled substances throughout the development lifecycle. Our teams understand the additional operational, regulatory, and security requirements associated with these programmes, helping clients navigate development challenges while maintaining compliance at every stage.

Whether you are developing a conventional small molecule therapy or a next-generation controlled compound, we provide the technical guidance and manufacturing support needed to advance your programme with confidence.

An Experienced Partner for Controlled Substance Programmes

Development Services for Controlled Drug Products

Our formulation scientists have experience developing a broad range of dosage forms containing controlled substances, including:

Dosage Form Expertise

  • Capsules
  • Tablets
  • Powder formulations
  • Oral liquids and suspensions
  • Nasal drug products
  • Pulmonary and inhaled formulations
  • Modified-release dosage forms

Development Activities

  • Pre-formulation studies
  • Formulation optimisation
  • Analytical method development and validation
  • Process development and scale-up
  • Stability studies
  • Clinical trial material manufacture

By integrating development and manufacturing activities under one roof, we help streamline technology transfer, reduce development timelines, and minimise project risk.

Controlled Substances

Sterile-finish isolator image with scientist working on biotech project.

Secure, Compliant and Flexible Development Support

Controlled substance programmes require more than technical expertise alone. They require a development partner with the systems, procedures and experience needed to manage regulated materials throughout development and manufacturing activities.

Upperton provides secure handling and compliant management of controlled substances, enabling clients to access the formulation, analytical and manufacturing support required to progress their programmes from early development through to clinical supply.

Speak to our team to discuss your controlled substance development and manufacturing requirements.

Contact us to discuss your molecule in more detail

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.

partnership

Why Partner with Upperton

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

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

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