Consultancy services are provided in many aspects of pharmaceutical development and analysis.
A list of capabilities is provided below. The list is not exhaustive, for any specific enquiries not mentioned below, please contact firstname.lastname@example.org.
- Portfolio management of outsourced activities:
We can work with you to select a suitable CDMO for your project needs, then provide the technical leadership and oversight of your development project at the selected CDMO.
- Pre-formulation/materials characterisation:
Preparation and/or technical review of strategies for pre-formulation and materials characterisation.
- Analytical development:
We can establish or develop analytical methods for use either ‘in-house’ by our client, or for use at a selected third-party laboratory. QPD Analytical Solutions has the expertise to prepare and write robust analytical methods into your own format suitable for regulatory review.
- Analytical method validation:
We can devise suitable validation plans (protocols) to conduct suitable validation of analytical test methods and prepare or conduct technical review of the validation report.
- Technical transfer:
Lead the technical transfer activities of a manufacturing process, analytical testing and/or stability study. We can propose a suitable strategy and execute through to a successful project transfer.
- Stability studies:
Design and prepare stability studies in accordance with ICH and WHO guidelines, or your own ‘in-house’ requirements. We can prepare or review stability protocols and/or reports. Based on the stability data generated, we can propose suitable retest periods (for API) or shelf life (for finished drug product). QPD Analytical Solutions have experience of the stability testing requirements for the annual product review of commercial lots.
- Preparation of regulatory documentation:
QPD Analytical Solutions has experience of the preparation of CMC sections for IMPDs or CTDs for product licence applications and can also provide a thorough technical review of these documents prior to submission to the regulatory authorities.
- Troubleshooting and problem solving:
We have experience of conducting thorough trouble-shooting and resolution of complex technical issues across pharmaceutical development, manufacturing and analytics using appropriate problem solving tools.
The emphasis is on high quality technical data provided in a timely manner. All activities are treated in total confidence and are typically subject to a Confidentiality Agreement.