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Access to the right resources that have the right track record and capacity is challenging. Navigating the world of vendors is daunting and finding a qualified service provider that supplies the resources your project needs can be complex. PharmaDirections' PharmaDirectNet® brings in a full network of partners to provide qualified, audited, SOP-driven alliances to draw from. PharmaDirectNet® provides you with open capacity for respective projects, supply chain management, and enhanced operating efficiencies through pre-existing service agreements, amplified scientific expertise, and project management oversight.
Management and execution by means of our service provider network provide benefits in 4 key areas:
•Breadth of services
•Quality and compliance
•Reliability and efficiency
•Speed and flexibility
Key Benefits
Breadth of services – Amplify scientific expertise and resources through an enabling network of laboratories and manufacturers.
•Preclinical
(more)>
Pharmacology and GLP Toxicology from mouse to primate;
All dosing routes and full analytical support from start to finish;
Standard and Specialized GLP protocols with full pathology support;
Efficacy pharmacology models
• Bio-analytical methods (more)>
Transfer, development and validation
• Analytical methods (more)>
Technology transfer of available analytical methods; Development of methods for new drug product formulations;
Analytical method validation as required by clinical phase; Support of formulation development and manufacturing;
Analytical methods for Drug Substance;
Analytical methods for Drug Product
• Formulation development (more)>
All routes of administration - oral, parenteral, topical; All dosage forms - capsules, tablets, topicals, parenterals, aseptic processing;
Clinical Trial Material to commercial;
Early development compound decisions;
Prototype formulations;
Laboratory stability evaluations;
Test article manufacturing for toxicology studies;
In vitro studies for product selection;
Packaging design and selection;
Packaging validation studies
• API Development and Manufacturing (more)>
Grams to commercial scale;
High potency, cytotoxic, and controlled substances;
Technology transfer of an available process;
Investigation of routes of synthesis;
Generation of reference; Standard
optimization of the manufacturing process;
Pivotal or clinical batches;
Scale-up and commercial manufacturing;
Process validation
• cGMP Drug Product Manufacturing (more)>
CMOs prequalified for all dosage forms - solid/oral tablets and capsules, sterile injectible, sterile lyophilized, liquids, semi-solids, medical devices; Phase 1, 2 and 3 clinical packaging and distribution; PAI preparation for commercial; Primary and secondary packaging design; Development reports; CMC compilation; Registration batches; Process validation
• Clinical Pharmacokinetics and Toxicology (more)>
Phase 1 units across the globe;
Bioavailablity;
Drug-drug interactions;
Bioequivalence studies;
PK modeling and analysis;
Bioanalytical support from validation to clinical-sample analysis
Quality and Compliance – Only qualified and audited service providers are employed for your program. Customize the plan and resources to meet your clinical study and commercialization needs across the full spectrum of drug development. The right resource applied at the right time.
•CMOs and CROs carefully selected
based on direct experience and reputation in the industry
•Service providers pre-qualified and audited
• US, EU, JP compliant facilities
• Assure quality
with cGMP, GCP, GLP compliant facilities
• Ensure global supply
with our duplicative and worldwide provider network
Reliability and Efficiency – Execute your program according to best commercial and scientific practices. Our established provider partners apply operating efficiencies.
•Multiple best-of-breed resources are identified to ensure available capacity
• Project Management
in place to coordinate communication in order to ensure timely decision making
Speed and Flexibility – Pre-existing business arrangements minimize time spent on non-value-added activities. Our provider partners supply capacity for your project and accelerated timing through effective project management and scientific oversight.
•Right resources brought to the table custom fit according to project needs
•Protect your IP and confidentiality
with CDAs that are already in place
•Established working relationships
with completed Master Service Agreements and Quality Agreements
•Accelerated project initiation
by project management processes that facilitate immediate communication
•Minimization of non-value-added activities
save time and money
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