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Pre-formulations


Preformulation is a stage of development during which the physicochemical properties of drug substance are characterized.

Remedex Pharmaceuticals offers a complete range of preformulation services to design to meet each client’s requirements.

 

Pre-formulation Studies

● Solubility determination
● pKa determination
● Partition co-efficient
● Crystal properties and polymorphism
● Particle size, shape and surface area
● Chemical stability profile
● Force degradation studies
● Surface area determination
● Characterization of drug substance
● Salt selection
● Powder flow properties
● Excipient Incompatibility Studies
● Physical and Chemical Characterizations

 

Technical Services

 

Remedex offer a complete range of pharmaceutical development and manufacturing capabilities to support your requirements including effective, robust and swift tech transfers, a full selection of proven and validated technology and process improvement solutions, competitive pricing, on time delivery.

● Product Development and development report
● Process Design and Development
● Process Optimization and Validation
● Process Trouble shooting and Improvement
● Technology transfer and Scale-Up
● Analytical Methodologies
● Clinical batches manufacturing
● Validation batch manufacturing
● Stability studies under ICH guideline
● Start-Up of new manufacturing site
● On-Site troubleshooting on formulations
● Troubleshooting manufacturing process
● High shear and Fluid Bed technology
● Batch record and other documentations


Product Development

Remedex Pharmaceuticals offer a wide range of product development and optimization services to our partners. Our streamlined pathway to pharmaceutical dosage form development includes Quality by Design (QbD) approach. We provide all the necessary resources to develop high quality product from formulation development to commercial production. Each formulation is unique and at Remedex, formulation projects start with a strategic formulation plan thorough analysis of the preformulation data report, the intended manufacturing critical process.
Remedex also can pursue an ANDA/NDA project from its inception through development and approval to launch stage.

Specialist

Remedex can develop the product having critical formulation development process.
● Product with Formulation Complexities
● Product with specialized release
● Product with specific challenge with low bioavailability
● Product with Poorly soluble drugs
● Product with Poorly permeability
● Product with Poorly physical stability
● Product with Regulatory challenge
● Product with raw material problems

 

Manufacturing and Packaging

Remedex Pharmaceuticals USA provides a higher standard manufacturing services includes a full range of manufacturing capabilities with c GMP compliance. Continuous monitoring by our Quality Management System and environmental testing ensure that the product meets high quality standards.

● 6 Segregated GMP manufacturing suites
● Pilot facility for scale up and process optimization
● Manufacturing CTM for Phase 1 and 2.
● Pilot and Pivotal Batches ANDAs for submission
● Manual packaging for CTM products
● Special lighting for light sensitivity materials
● Labeling and packaging for all dosage forms
● GMP training
● Equipment and facility validation
● Change control (Quality System and Procedural)
● Multi product facility


Analytical Services

Remedex Pharmaceuticals USA coupled with highly skilled team can examine and troubleshoot challenging analytical requirements.

Methods are validated in compliance with current ICH guidelines. Our analytical services include:
● Method Development including complex issues
● Method validation and Transfer
● Cleaning Validation
● Method Transfer
● Testing of Raw Materials and Finish Products
● Stability Storage and Testing
● Identification of Impurities
● Assay, Dissolution and Disintegration tests
● Microbial limit testing
● Antimicrobial Effectiveness Testing (AET)
● Preparatory testing

Drug Delivery Technology

The mission of the Division of Drug Delivery Technology is to provide new strategies for the delivery of biologically active compounds at the right dose, at the right time and at the right place. In order to achieve this, novel drug delivery systems are designed and the interactions of these delivery systems with biological systems are investigated at the (sub) cellular, tissue and organism level, both in vitro and in vivo.

Currently the division focuses on following research themes:

● Small molecule Formulation: Solubility and Bioavailability
● Control Release Drug Delivery System
● Targeted Release System
● Solid Dispersion Development
● Particle Size Reduction Technology
● Inhaled Drug Delivery System
● Poorly Soluble Drugs
● Poorly Absorbable Drugs
● Lipid solubilizes

Quality Control and Assurance:

In Remedex Pharmaceuticals every activity from procuring of materials to final shipment of the consignment to the customers in monitored and inspected to provide the high quality products. The system and process are supervised on on-going basis to ensure the final product meets the needs of the customers.

Our Quality Control Points

Some of them include:

● Quality Polices and guidelines
● SOP management
● Training management
● Suppliers qualification program
● Change control and CAPA
● Analytical method development and Validations
● In-process control of production operations
● Sampling of raw materials, packaging materials and finish products for analysis
● Finish product release
● Maintain internal instrument qualification and calibration
● Stability testing of products
● Incidents
● Complaints
● And more….


 

Regulatory and Compliance:

Remedex Pharmaceuticals is committed to manufacture high quality products in total compliance with regulatory requirements. All process and manufacturing operations are in according with c GMP requirements, US FDA and ICH guidelines and regulations. Remedex Pharmaceuticals offers following services on regulatory and compliances.

● Consulting on IND, NDA and ANDA Submissions
● Review and counsel on Clinical, CMC and bio-analytical issues
● Post approval Changes consultations
● Labeling
● FDA meeting on regulatory issues
● Technical services on FDA 483, warning letters and consent decree