Resource Center
White Papers and Case Histories
In this section, you will find a variety of scientific papers, white papers and case histories focused on drug development, pharmaceutical manufacturing and packaging for semi-solid and liquid dosage forms. These documents are presented in Adobe PDF format for your convenience.
| Effective Controlled Substances Supply Chain Management: What You Need to Know to Ensure Compliance and Optimize Efficiency | Controlled substances are highly regulated and must be vigilantly monitored from the laboratory to the marketplace to prevent theft and illicit sale in the black market, a growing trend. In addition to abundant federal and state regulations, increased globalization – with its stringent import and export restrictions, permits and declarations required for controlled substances – has made compliance even more challenging. Partnering with a CDMO experienced in supply chain management of controlled substances can prevent costly delays, steep penalties for noncompliance, and the potential postponement of a clinical trial |
| White Paper: Ensuring Quality & Regulatory Compliance when Collaborating with a Service Provider | With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure Current Good Manufacturing Practices cGMP are top of mind, and sponsors are placing greater responsibility for meeting cGMP requirements onto their outsourcing partners. |
| White Paper: Ensuring a Streamlined Approach for Nasal Spray Product Development & Manufacturing | Because the efficacy of the drug product depends on the ability of the spray device to deliver reproducible plumes and uniform dose content, some aspects of nasal spray development are unique such as formulation, container closure system, plume characterization, manufacturing and stability testing. Therefore, these aspects need to be carefully considered during the development program. |
| White Paper: Key Steps to Consider When Working with a CDMO to Identify Optimal Packaging Options | There are many factors to take into consideration when selecting or designing a packaging component. Steps involved during the initial stage of the process are extremely important in ensuring that the most optimal packaging is identified. Working with a contract development and manufacturing organization (CDMO) early in the process helps eliminate packaging problems that may arise after the development stage. |
| White Paper: CDMO Best Practices | Industry reports identify a growing competitive landscape internationally, which has created a greater demand for outsourced services; but how does one find a contract development and manufacturing organization (CDMO) with the appropriate capabilities, expertise, readiness and proven ability to transition from concept to commercialization? This white paper provides key elements to consider when selecting a CDMO. |
| White Paper: Inhalation Drug Delivery ‐ Understanding Basic Steps Involved in pMDI Development | Drug delivery via the inhalation route is an efficient, safe and efficacious method for local and systemic administration of certain therapeutic agents.This white paper provides insight into the aspects of formulation development, packaging development and analytical development associated with inhaled drug delivery as it relates to pressurized metered dose inhalers (pMDI). |
| White Paper: Analytical Method Development and Validation – A CDMO Perspective | A Contract Development and Manufacturing Organization (CDMO) that understands customer needs, regulatory requirements and has a proven track record for developing and validating analytical methods can minimize developmental costs and reduce the time to market. Properly validated drug product characterization methods are necessary for regulatory filings, but can also reduce overall turnaround time during scale-up, clinical release and commercial release. |
| White Paper: Partnering with Your CDMO for CMC Preparation | Collaborative partnering between Contract Development and Manufacturing Organizations (CDMO) and the drug product submission applicants (Applicant) is becoming increasingly important with the emphasis on product design by regulatory agencies. The CDMO can provide the appropriate resources to build the scientific knowledge base for the product and the depth of science-based information for the drug design and development that are required in the CMC sections of the application. |
| White Paper: Effective ICH Q8 Pharmaceutical Development Reports | The International Conference on Harmonization (ICH) Common Technical Document (CTD) format is the submission standard for new and abbreviated drug product applications in the United States, the European Union and Japan. One of the significant sections of the CTD is the Pharmaceutical Development Report (PDR). A complete PDR is essential to provide a comprehensive understanding of the product and process for the FDA application reviewers and inspectors. The information in the PDR is based upon the documentation generated during the formulation and process development phase of drug development. |
