A drug product’s success relies largely on the quality and effectiveness of the raw materials used in the manufacturing process, mainly the active pharmaceutical ingredients (APIs) and the associated excipients used in the formulation.
While the APIs are responsible for generating the desired pharmacological effect, it is the excipients that play a central role in the drug development process. Used in a wide range of drug products such as capsules, tablets, oral liquids, and injectables, they facilitate absorption, provide drug stability, and help overcome challenges with poorly soluble APIs, allowing them to be formulated and developed.
We can help source, purchase, and test APIs and excipients to ensure your drug product’s effectiveness and timely delivery to market.
Our raw material services are low cost, and delivered in a timely manner to meet your budget and timelines. Our scientists work with state-of-the-art equipment and strict procedures for method development and validation, and provide quick-release testing for all necessary components. We also manage all necessary United States Pharmacopeia/National Formulary (USP/NF) and European Pharmacopeia (EP) testing for materials received, with a rapid release from our on-site analytical laboratories, or our industry-known laboratory partners.
Our full range of raw material services include:
The packaging of a pharmaceutical product ensures the safe delivery of the drug to the end user, from manufacturing through commercialization.
Altasciences’ scientists work with the latest technology to ensure the packaging used for your drug product adheres to FDA and EU regulatory requirements, and fulfills its primary goals:
- Maintain the effectiveness and quality of the active pharmaceutical ingredients (API) in order to produce the highest quality drug product (e.g., tablets, liquid-filled capsules, injectables)
- Preserve and/or improve the drug product’s shelf life
- Protect the product from external factors such as transit hazards, moisture, gases, insects, etc.
- Ensure its convenience and safety as a dosage form for the end user
Our manufactruing team can help you decide which packaging components are best suited for your pharmaceutical product based on different criteria, such as its chemical components, stability, and level of required sterilization. Types of packaging commonly used include glass, plastic, and metal containers, bottles, vials, as well as paper board, rubber, cotton, adhesives, closures, and various type of films, foils and laminates.
Do you need help with raw materials or pharmaceutical packaging components? Send us a message.