Formulation Development

We are a leading provider of contract drug product clinical development, commercial manufacturing, and analytical services to all sectors of the pharmaceutical industry.

Like our customers, we are passionate about making a difference in the lives of patients. Our experience in complex oral solid dosage forms, topicals and oral liquids, particularly in the area of controlled substances (CI-CV) is unmatched in the CDMO space. With experience in new molecules and generics, we focus on solving the complex formulation, analytical and manufacturing challenges our clients face. At Halo Pharma, we collaborate with you every step of the way to ensure you achieve your development goals so you can bring your product to market quickly.

While we excel at all of our scientific and manufacturing know-how, we strive to be the best partner. We are collaborative and responsive, working with customers to find effective and expedient solutions to their development and manufacturing challenges. We are innovative and explore new ideas and approaches. We are agile and flexible, we can easily accommodate changes that may arise in the needs of a customer’s project at any point in a product’s life cycle.

Our competitive advantages include a unique ability to manufacture complex and difficult to manufacture products with a special focus on controlled substances and abuse deterrent technologies.

Specializing in all aspects of the CMC dosage form section of the NDA, our highly-skilled technicians and scientists, laboratories and pilot facilities can expedite bringing your molecule through the clinical development lifecycle and ultimately to market.

Development Services

Project Management

Experienced Project Managers serve as the primary point of contact for the client. Your Project Manager will act as your interface with each of the Halo functional groups overseeing the activities and the progress of your project.

Formulation Development

Complex modified release dosage forms are our expertise. Our formulation scientists and analytical chemists execute excipient compatibility studies, Pre-Formulation, Formulation and Quality by Design activities to ensure your product meets your clinical objectives and milestones.

We can provide small-scale proof of concept prototype batches, manufacture clinical trial materials; perform scale up manufacturing and registration batch manufacturing as well as perform technical transfer and validation services in preparation for Commercial Manufacturing.

Analytical Development

We provide the technical expertise to develop your analytical methods from early phase pre-clinical through phase III providing the method development and validation support you need for your CMC submission. Our comprehensive stability services cover all ICH storage conditions.

Potent Compound Handling Capability

Halo Pharma can also support potent compounds in a variety of dosage forms including OEL between 1-10 ug/m3

Types of Containment Equipment Onsite

  • EHS Solutions Weighing Isolator
  • Laminar Flow Weigh Booths
  • Weigh Hood Enclosures
  • ChargePoint Split Valves
  • Ventilation Sleeves