Insight Pharma

Research & Development

Pharmaceutical R&Ds are facing unprecedented business pressures, including increasingly stringent regulatory requirements, unsustainable fixed-cost models, and the complexity of managing numerous vendor partners and technology systems.

IBRSoluTions provides innovative solutions that help companies focus on the science of getting new products to customer faster and maximize their returns on R&D investments. We help in focusing on customer engagement throughout development, advancing the next generation of R&D operating models resulting in better collaboration, driving scientific and operational excellence and enabling efficient information analysis and harnessing the digital R&D revolution, using real world data to address customer needs. We provide various R&D support to both API and formulation companies.

IBRSoluTions provides the following Research & Development Services:

Research & Development Services
  • API Process Research & Development

  • Drug Product Research & Development

  • Manufacturing Consulting

  • Supply Chain Management

  • Pharmaceutical Analysis

  • Quality Assurance & Compliance

API Process Research & Development

  • IBRSoluTions has unparalleled synthetic organic chemistry expertise helping API research and manufacturing companies to synthesis API in safe and cost effective pathway. We work assisting API manufacturing companies from early stage of API synthesis to setting commercial scale processes and operations for late stage or commercial products. We work on technical transfers, DoE, validation, and manufacturing oversight. We help clients by our expert advice in following areas in API development:
    • Synthetic Process Mapping
    • Expert review of existing routes
    • Novel routes suggested by process experts
    • Synthetic Route Selection
    • Non-infringing synthetic process of API manufacturing
    • Regulatory Starting Material Definition
    • IPC & PAT Method Development Strategy
    • pGTI (Potential Genotoxic Impurities) review
    • Analytical Strategy Development
    • Analytical methods to minimize scale-up and quality issues
    • Report Documentation
    • Rigorous evaluation of cost of goods
    • Processes operating robustly and safely at scale, ensuring security of supply
    • Identification of cost reduction strategies for existing API syntheses
    • Resolution of scale up issues to avoid costly delays in compound supply
    • Salt selection and physical form control

Drug Product Research & Development

  • Formulation development to determine the optimal dosage form, composition and manufacturing route is a fundamental part of pharmaceutical product development. Getting a pharmaceutical formulation development right helps to optimize drug delivery performance and product stability. Expertise is required in various fields like pre-formulation, excipient-API compatibility assessment and optimization, physicochemical testing, formulation screening, lab scale formulation and accelerated stability studies to achieve the desired characteristics of formulation and to achieve accelerated project timelines.

    IBRSoluTions provides drug product research & development consulting services helping pharma and biotech companies in their formulation development efforts. We have experts from industry having wide experience in formulation process development, scale up, and commercialization of all sorts of dosage forms. Our specialists can screen a wide range of formulations in a timely and cost-effective manner in order to identify the most promising formulation to progress through to further development. We help clients by our expert advice in following areas in formulation development:
    • Evaluation of formulation options
    • Determination of goals of drug product form
    • Formulation options suggested by pharmacy experts
    • Evaluation of strongest options
    • New idea for formulation development
    • Non-infringing Formulation development
    • Solve formulation problems with a designed experimental program created by our experts
    • Work out placebo and comparator issues
    • Excipients/Ingredient Selection
    • Report Documentation

Manufacturing Consulting

  • Pharmaceutical manufacturing is the most neglected function in the value chain, with a cause no problems mentality focused on getting enough manufactured product through extensive quality controls to meet market demand. But today’s pharmaceutical products are more complex, cash is scarcer, and quality requirements require more fundamental understanding. The products are complex, delicate and difficult to manufacture but manufacturing techniques have not kept up with advances in science and technology. So lean manufacturing process and cost-cutting is need of today’s pharmaceutical manufacturing sector.

    IBRSoluTions provides manufacturing consulting services helping clients to improve their manufacturing process methodologies that deliver measurable and sustainable improvements in the areas of asset optimization, unit cost reduction, quality improvement, safety performance and project execution. We helps our clients solving manufacturing problem by taking into account the specific pressures faced in manufacturing operations to find business solutions in every level of the manufacturing process. The pressures brought about by limited resources, cost pressures from global competition and ever segmented customer demand are challenging and powerful forces that can cause large inefficiencies in productivity.

    We develop practical, meaningful solutions understanding manufacturing and compliance needs of clients, which address immediate concerns and continue to deliver real value in the long term, helping companies, achieve sustained, cost-effective performance improvements. We expertise in following manufacturing consulting activities:
    • Establishing flexible quality systems which are able to quickly and efficiently evolve to meet the changing regulatory landscape.
    • Developing lean, streamlined, clearly defined manufacturing processes which are able to respond to changing manufacturing, supply chain and cost pressures.

Supply Chain Management

  • A healthy supply chain to the internal customer requirement is most essential to drive R&D activities in a pharmaceutical company. As all drug, device, biologics and dietary supplement manufacturers purchase raw materials, components and services from external suppliers, a proper supply chain management system will enable them meeting their targets, expand their reach and keep pace with rising expectations. In healthcare sector, it is not only the supplying goods but also quality matters. So each company has the responsibility to make sure that their suppliers conform to various quality standards.

    IBRSoluTions provides supply management services helping our clients to identify low cost, but reliable sources of API, products and packaging materials and put these together to maximize their return on product investment. We help procurement teams to enable them meeting their targets, expand their reach and keep pace with rising expectations. We assist with overall strategy, implementation and on-going supply chain management that could impact your supply chain, including manufacturing planning, raw material sourcing, materials planning, vendor selection, cost of goods, inventory planning, and supply redundancies and integrity. We expertise in following supply chain management activities:
    • End-to-end Supply Chain Assessment and Optimization
    • Technology Transfer Planning and Management
    • Vendor Selection
    • Vendor Audits and Management
    • Cost of Goods Evaluation
    • Inventory and Contingency Strategy

Pharmaceutical Analysis

  • Pharmaceutical analysis services play an important role in both the development process and GMP manufacturing. Concerns about drug safety, costly development programs, complex manufacturing, market demands for evidence-based data and increased regulatory requirements are all issues that can be addressed through a better understanding of your drug substance, drug product or manufacturing process which, in turn, can only be achieved through experienced analytical studies and robust analytical data.

    IBRSoluTions provides analytical development consulting services helping companies to accelerate their development process, achieve the right data to complete marketing authorization submissions and support your post-marketing requirements. Our experts have comprehensive methods development and validation experience to resolve various issues during analytical process. We expertise in following analytical consulting activities:
    • Analytical Strategy Development
    • Analytical Testing/Validation Strategy
    • Drug Product Analytical Methods Development
    • Analytical Strategy Development
    • IPC & PAT Method Development
    • Drug Product Analytical Methods Development
    • Report Documentation

Quality Assurance & Compliance

  • Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. Quality assurance in pharmaceutical industry contributes to public health by enabling safe, effective and appropriate quality medicines to reach patients. The quality of pharmaceutical products is ensured by the technical and managerial activities of the quality system. The technical activities include evaluation of pharmaceutical product documentation, reviewing quality control laboratory tests, and monitoring product performance whereas managerial activities include selecting reliable suppliers, preparing contracts terms, monitoring supplier’s performance, and performing inspection procedure throughout the distribution network.

    IBRSoluTions provides quality assurance and compliance consulting service focused on the highest level of cGMP Quality Assurance for all stages of development and manufacturing. Our experts are pharmaceutical industry veterans with years of industry experience. Our team is experienced in API and Drug Product cGMP compliance for both small and large molecules, and also medical device cGMP. We help pharmaceutical companies to set up the right quality systems covering the entire product lifecycle from product development and manufacture through to packaging, labeling and distribution. We expertise in following quality assurance & compliance consulting activities:
    • Preparing and managing required SOPs for cGMP compliance
    • Reviewing manufacturing processes and submitted data
    • Reviewing manufacturing facilities and quality management systems
    • Providing written gap analysis and proposing compliance improvement opportunities
    • Audits of contractor facilities for supplier selection or GMP compliance
    • Work with in-house QA experts to improve presentation of facility and systems for Inspector
    • Prepare response documents or appeals
    • Identification of suppliers for API, drug product, distribution and marketing
    • Supply chain optimization for worldwide distribution of CTM and products
    • Lean manufacturing and six sigma optimization and implementation of manufacturing and supply
    • Qualified Person services
    • Training staff in cGMP policies and compliance
    • Prepare and execute Quality Agreements with contract manufacturers (CMOs/CDMOs)

Copyright © 2019 IBRSoluTions. All rights reserved Hand crafted by Techno source IT Solutions