Formulation Development Services
Getz Pharma Research offers the following three models for contract development services:
- Fee for service
- Co-development
- Product out-licensing
The range of services include:
- Complete dossier development including technology transfer
- Development of analytical methods
- Method validation of stability indicating analytical methods
- Stability studies
- Multimedia dissolution profiling studies
- Innovator product profiling studies
A dosage form development program generally includes pre-formulation studies, excipient compatibility studies, analytical methods development and validation, formulation development and optimization, stability studies, support to the client in preparation of the Chemistry, Manufacturing and Controls (CMC) section of the submission document, manufacturing process development, cGMP manufacturing of clinical trial materials, and formal stability studies according to ICH Guidelines.
Getz Pharma Research initiates each drug development program with major consideration for implementing the most effective regulatory strategy to achieve near and long-term goals. We believe potential issues addressed early will accelerate overall development time.
Getz Pharma Research offers a customer-oriented, preformulation testing program based on the composition and intended delivery of the drug product. Physiochemical testing based on compound solubility and stability across a broad range of conditions is critical to identifying the best formulation strategy for a particular compound. Interpretation of the preformulation study data requires strong analytical method development skills, which provide the scientific backbone on which clinical formulations are based.
Product Development Strategy
Getz Pharma Research conducts extensive data review prior to submitting a product development strategy to customers. This includes, but is not limited to, Sci-Finder searches, patent reviews, collation of market information and financial projections, sourcing of API, short-listing suitable manufacturing facilities and clinical/bio-analytical facilities, and regulatory understanding.
Proof of Concept Notes
These are referred to as "feasibility reviews." In most cases, this includes minimal experimentation and confirmation of the concepts proposed prior to initiation of full-fledged development. These studies involve regulatory and IPR inputs to a large extent.
SUPAC Applications and Regulatory Compliance
A critical aspect of our responsibility to our clients is to ensure compliance with the changing regulatory guidelines and requirements, as well as adapting our services to the emerging trends in submission procedures and technologies. Sound academic qualifications and broad-based practical experience allows our personnel to undertake a variety of scientific review functions on behalf of our clients. We ensure compliance with the evolving regulatory requirements of the pharmaceutical industry, and thus are able to proactively advise clients on strategic changes that may need to be incorporated on a timely basis.
ICH Interpretations
We recognize the importance of timely and accurate regulatory submissions as well as the need to foster and coordinate a team effort in drug development. Our Regulatory Affairs team and affiliates have extensive pharmaceutical drug development experience and offer customized regulatory solutions through every phase of product development, review and commercialization.
Chemistry, Manufacturing and
Control Section Preparation for Submissions
Getz Pharma Research has a competent regulatory department involved in the preparation of regulatory documentation conforming to FDA, MHRA, MCC, TGA, TPD and other regulatory bodies. The team is also well-versed in preparation of submission documents conforming to the CTD format. The major advantage of the regulatory team lies in having ready access to development, manufacturing, analytical and stability data from all the various departments like API, product development and bio-analytical sections, which streamlines the collated data into a coherent document.