Development
Pharmoveo offers technical project management for pharmaceutical development projects. Our formulation specialists create necessary experimental designs and corresponding analysis. They create plans for process development and process optimization following the quality by design approach. Special expertise exists in the pharmaceutical development of poorly soluble, poorly stable and highly potent active pharmaceutical ingredients. Our experts have several years of leadership experience and will as well work on projects at Your company site together with your coworkers.
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Our portfolio:
Pharmoveo undertakes the technical project lead within the area of pharmaceutical development. Flexibility is our first priority in order to suit Your project needs best. Therefore Your assignment to us can include one or several of the following options.
Head of the Department or Head of Laboratory as a Temporary Replacement
Our experts have several years of experience as head of department or head of laboratory within the pharmaceutial industry. According to Your needs they will coordinate Your pharmaceutical development projects from predevelopment to transfer stages. As necessary they will as well take over the responsibility not only for the performed pharmaceutical development work, but as well for the management of personnel, budget and invests to be performed.
Pharmaceutical Development Expertise
Our experts are specialists in the field of pharmaceutical development. They will be a benefit for Your company within the following areas:
[one_half]Formulation Development
Our formulation specialists will guide Your projects on temporary or long term basis. Project work may include anything from first compatibility studies through small scale trials. It can be formulations for pharmacological studies or products to be transfered into production. Experimental designs will be performed according to the quality by design (QbD) approach and can be based on statistical designs according to the design of experiments (DoE) approach. We favor to include the input of the project group as much as possible from planning to analysis stage. A strong interaction with the corresponding analytical personnel is favored as well. Our experts will write reports. They are glad to do so directly in the common technical document (CTD) format. Presentations to the management will be performed as well as participation in projects meetings as desired.[/one_half][one_half last]Process Development and/or Optimization
Our technolgy specialists have experience in the development and optimization of basic as well as complex technological processes. Some are also experts in the field of challenging process techniques such us melt extrusion. With increasing numbers of poorly soluble or hydrophobic drugs the importance of this technology is growing constantly. Experience exists as well in handling of poorly stable active pharmaceutical ingredients (API) when especially gentle manufacturing techniques are required. We will be happy to bring in our expertise as well when handling of high potent substances needs to be prepared, e.g. using the isolator technique.[/one_half]
Pharmaceutical Development
The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the establishment of the design space, specifications, and manufacturing controls.
Information from pharmaceutical development studies can be a basis for quality risk management. It is important to recognize that quality cannot be tested into products, i.e., quality should be built in by design. Changes in formulation and manufacturing processes during pharmaceutical development and lifecycle management should be looked upon as opportunities to gain additional knowledge and further support establishment of the design space. Similarly, inclusion of relevant knowledge gained from experiments giving unexpected results can also be useful. In pharmaceutical development the design space is proposed by the applicant and is subject to regulatory assessment and approval. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory postapproval change process.
The Pharmaceutical Development section of a regulatory submission should describe the knowledge that establishes that the type of dosage form selected and the formulation proposed are suitable for the intended use. This section should include sufficient information in each part to provide an understanding of the pharmaceutical development of the drug product and its manufacturing process. Summary tables and graphs are encouraged where they add clarity and facilitate review.
At a minimum, those aspects of drug substances, excipients, container closure systems, and manufacturing processes that are critical to product quality should be determined during pharmaceutical development and control strategies be identified. Critical formulation attributes and process parameters are generally identified during pharmaceutical development through an assessment of the extent to which their variation can have impact on the quality of the drug product.
