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Our Pharmaceutical Development domain develops the best possible formulation to meet your clinical studies and commercialization needs. Our large group of scientific product development staff, combine expertise in analytical, formulation, and process development for drug substance and Phase 1-3 drug products to enable our clients to create and assess new commercial opportunities and intellectual property as well as develop and risk mitigate associative manufacturing and stability issues. We can also provide you with deep scientific and regulatory assistance for preparation of IND/NDA CMC sections.
Key Benefits
Proven ability to develop, manufacture, and package all types of stable dosage forms at any stage of development provides our clients with the confidence that their final product will be successfully developed and manufactured for commercial launch
• Proven experience with all types of dosage forms such as immediate and controlled release tablets and capsules, oral solutions and suspensions, topical creams and ointments, nasal sprays, inhalation products, transdermal patches, and injectable sterile solutions and suspensions.
• Supply chain expertise for moving into commercial production and negotiating supply agreements for drug substance and drug product contract manufacturers, and raw material and packaging component suppliers. We have established relationships with multiple contract development firms for laboratory and pilot scale development, commercial scale manufacturing, packaging for clinical studies, and development of testing procedures for drug substances and drug products
• Capability and interest to execute either your entire development program from Phase 1-3 product development to commercial manufacturing launch, or selected parts, e.g. Phase 1 clinical supplies, manufacturing scale up or manufacturing site transfers
• Regulatory Affairs support to prepare CMC sections for drug product IND’s and NDA’s, or drug device applications, attend IND and PreNDA FDA meetings, address IND and NDA FDA reviewer CMC questions, and prepare for FDA NDA Pre-Approval inspections
Expertise in formulating unique dose forms for use in preclinical pharmacology and toxicology studies allows clients to move quickly into non-clinical studies
• We have staff with extensive knowledge in designing test articles that will meet the requirements for unique dose forms for use with in-vitro pharmacology and in vivo animal drug activity, pharmacokinetic, and toxicology studies
• Deep scientific expertise for API synthesis development, product formulation and process development, analytical development and manufacturing of preclinical and Phase 1-3 API and dosage forms allows us to anticipate problems and overcome difficult challenges at all stages
• Our formulation team experience facilitates fast and reliable development of all dosage forms
•Our extensive list of drug substance and drug product development experts allows us to assign team members that have the specific expertise to best manage and trouble-shoot your project
•Our combined staff experience easily exceeds 50 IND’s, 25 NDA’s, and numerous patents for unique dose forms
Flexibility to customize the project plan to meet your clinical study and commercialization needs means that our clients can move quickly and respond rapidly to program changes
• Detailed development and manufacturing strategic plans are prepared to provide a step by step process listing all milestones that are necessary for a program’s success; PathfINDAr™, through approximately 1600 lines of activities, provides a very specific outline of each development step, associated time and costs for your project.
• Each of the project steps in PathfINDAr™, was developed by the expert responsible for the specific project step, such as analytical method validation, reference standard preparation, stability testing, formula development, etc; The complete plan integrates all the steps recommended by the individual experts.
Routinely incorporating risk mitigation in development of dose forms, test procedures, stability studies, and manufacturing scale-up keeps our projects moving forward
•Risk mitigation is incorporated along the entire pharmaceutical development path from Phase 1 development of prototype dose forms to manufacturing qualification and validation of commercial products
•The extensive experience and expertise of our staff allow anticipation or remediation of unexpected technology issues. Studies are planned to ensure problems do not occur or to quickly solve challenges for minimal effect on project completion
Creativity in assessing new commercial opportunities and intellectual property (IP) related to repurposing/ new delivery systems translates into exclusivity for our client’s products
•Assessment of the commercial and technical viability of a pharmaceutical product concept and advice on the probability of achieving patentability for protected marketing of product can be quickly performed
•Our extensive knowledge of products and dosage form technology allows us to identify alternative product opportunities for our clients around their proposed products
•A strategic plan can be developed for reformulation activities of the marketed product to generate and support the identified IP
•PharmaDirections gives royalty free IP rights to project sponsors
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