Your SlideShare is downloading. ×
0
Analytical & Product Development Services  Capabilities Presentation 17 June 2010
RPS  Analytical & Product Development Services …  Keeping Development and Manufacturing Strategies on Track
RPS - Analytical & Product Development Services <ul><li>Laboratory expertise integrated  into your infrastructure </li></u...
<ul><li>Mechanistic understanding of processes, applying scientific 1 st  principles to support development needs.  “Added...
Superior Scientific and Technical  Leadership Innovative and Lean Laboratory Management Comprehensive Development and Manu...
Comprehensive Development and  Manufacturing Strategy Comprehensive Development and  Manufacturing Strategy Case Study #1:...
Superior Scientific and Technical Leadership Superior Scientific and Technical Leadership Case Study #2:  Model Laboratory...
<ul><li>Rescue Project </li></ul><ul><li>Transition from Traditional Staffing Model </li></ul><ul><li>Highly Experienced T...
Highly Trained and Experienced Staff Leverage New Technologies and Operating Processes Identify and Follow a Systematic Ap...
…  Keeping Development and Manufacturing Strategies on Track RPS  Analytical & Product Development Services
Upcoming SlideShare
Loading in...5
×

RPS Analytical &amp; Product Development Services

510

Published on

capabilities overview

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
510
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
12
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide
  • We hope this information demonstrates how RPS is able to stabilize resources and improve efficiency. As you think about the challenges facing your laboratory, please remember RPS Analytical &amp; Product Development Services; we can help keep your Development and Manufacturing Strategies on Track.
  • Through our corporate headquarters located in Fort Washington, Pennsylvania, (click) RPS supports CMC activities, for Pharmaceutical, Consumer and Device Companies, in all phases of product development from Discovery to Development to Manufacturing. (click) Our teams will streamline your testing operations by organizing people and equipment for maximum workflow efficiency. (click) When delivering these services, RPS applies leading edge technologies and Lean Lab practices, delivering quality data that you can trust; efficiency that you can measure and full or integrated services that are unsurpassed in the industry.
  • RPS Analytical &amp; Product Development core competencies are comprised of 3 main categories: Superior Scientific and Technical Leadership; Innovative and Lean Laboratory Management; and Comprehensive Development and Manufacturing Strategy. (click) Our Scientific Leadership Group will have a mechanistic understanding of processes, applying scientific 1st principles to support your development needs. Our “added-value” RPS scientists maintain your strategic direction and will oversee processes on-site that help control project costs. (click) Highly experienced managers and supervisors employ new technologies and automation in a “Lean Lab” environment that lead to consistency and reliability. (click) Lastly, our strategic approach is a resource sparing model, following the concepts of “Quality by Design” to identify and mitigate risks associated with product development and manufacturing.
  • RPS offers a wide range of customized cGMP laboratory solutions, as demonstrated in 3 case studies: Our first example shows a full spectrum “Concept to Product” Development Program where RPS is currently supporting a Pharma company that is seeking to introduce several recently acquired products to the US market. A multifunctional laboratory infrastructure was put into service to perform CMC activities ranging from original IND submission to product commercialization. The services required include: Evaluation of existing laboratory production methods Method development appropriate to phase Testing and equipment validation Batch release testing And complete regulatory documentation control
  • Our second case study demonstrates a more focused “Model Laboratory Program” designed to support a few specific functional areas in a cGMP laboratory. These RPS functional groups include: Raw Materials, Analytical, Microbiology, Formulations and Stability teams. This multifunctional infrastructure was set up using facilities that were unoccupied and equipment was in storage and not being used. While RPS brought the lab up to be compliant with GMP standards a Governance Committee was created guided by long-term Contractual Agreement designed to support ongoing ad hoc requests. In this case several subsidiaries of this sponsor company are utilizing our unique Laboratory Model located conveniently within their own facilities.
  • The third case study illustrates how RPS was able to resolve a specific problem related to staff retention, which was negatively impacting efficiency ratings. In this Rescue Project case study, the Sponsor decided to transition from a Traditional Staffing Model to a highly experienced RPS team. Immediately headcount was reduced using an innovative lean lab approach applying the concepts of Quality by Design to increase Efficiency and Retention Metrics from less than 30% to over 90%. Productivity was put back on track and a Cost of Goods Analysis concluded that the Return on Investment will range from $1-5 million per year. Consequently , the RPS team was asked to remain in this sponsors’ laboratory permanently to continue supporting their growing needs.
  • In summary RPS, provides laboratory support to pharmaceutical, consumer and device companies supporting CMC activities throughout all phases of product development. (click) Our Superior Scientific and Technical Leadership offers Highly Trained and Experienced Staff; our Innovative and Lean Laboratory Management leads to the implementation of New Technologies and Operating Processes and Comprehensive Development and Manufacturing Strategies empower our experts to Identify and Follow a Systematic Approach to Development.
  • As a market leader in providing flexible integrated and full service solutions, RPS applies this same unique model for companies seeking GMP Lab services. (click) RPS Analytical and Product Development Services specializes in keeping development and manufacturing strategies on track.
  • Transcript of "RPS Analytical &amp; Product Development Services"

    1. 1. Analytical & Product Development Services Capabilities Presentation 17 June 2010
    2. 2. RPS Analytical & Product Development Services … Keeping Development and Manufacturing Strategies on Track
    3. 3. RPS - Analytical & Product Development Services <ul><li>Laboratory expertise integrated into your infrastructure </li></ul><ul><li>Expert staff + value-added RPS management </li></ul><ul><li>Integrated into IM infrastructure and core development teams </li></ul><ul><li>Flexibility to adjust based on project demands </li></ul><ul><li>Maximum usage of facilities and equipment </li></ul><ul><li>Positive Return on Investment (ROI) </li></ul>… for Pharmaceutical, Consumer and Device Companies Analytical Method Development and Validation, Drug Substance and Product Characterization, In-Process Testing, Stability Testing, Formulations, Microbiological Testing, Release Testing, Quality Assurance/Quality Control Discovery Development Manufacturing cGMP cGMP cGMP C hemistry, M anufacturing and C ontrol (CMC) Activities
    4. 4. <ul><li>Mechanistic understanding of processes, applying scientific 1 st principles to support development needs. “Added-value” RPS scientists maintain your strategic direction and oversee processes on-site. </li></ul>Core Competencies Overview Superior Scientific and Technical Leadership Innovative and Lean Laboratory Management Comprehensive Development and Manufacturing Strategy Highly experienced managers and supervisors employ new technologies and automation in a “Lean Lab” environment that lead to consistency and reliability. Utilize a resource sparing model following the concepts of “Quality by Design” (QbD) to identify and mitigate risks.
    5. 5. Superior Scientific and Technical Leadership Innovative and Lean Laboratory Management Comprehensive Development and Manufacturing Strategy RPS Analytical & Product Development Services Case Studies
    6. 6. Comprehensive Development and Manufacturing Strategy Comprehensive Development and Manufacturing Strategy Case Study #1: “Concept to Product” Development <ul><li>International Data (licensed-in) </li></ul><ul><li>Multifunctional Infrastructure </li></ul><ul><li>Original IND to commercialization </li></ul><ul><li>Evaluation of existing methods </li></ul><ul><li>Method development appropriate to phase </li></ul><ul><li>Validation </li></ul><ul><li>Release testing </li></ul><ul><li>Documentation (Regulatory) </li></ul>
    7. 7. Superior Scientific and Technical Leadership Superior Scientific and Technical Leadership Case Study #2: Model Laboratory Program <ul><li>Multifunctional Infrastructure </li></ul><ul><li>Facilities and equipment repurposed </li></ul><ul><li>Governance Committee </li></ul><ul><li>Long-Term Agreement </li></ul>Added-Value RPS Leadership Team
    8. 8. <ul><li>Rescue Project </li></ul><ul><li>Transition from Traditional Staffing Model </li></ul><ul><li>Highly Experienced Team </li></ul><ul><li>Reduced Headcount </li></ul><ul><li>Productivity Back on Track </li></ul><ul><li>Efficiency Metric </li></ul><ul><ul><li>< 30% to 90% </li></ul></ul><ul><li>Retention Metric </li></ul><ul><ul><li>< 30% to 95% </li></ul></ul>Return on investment (COGS Analysis) $1-5 million / year Innovative and Lean Laboratory Management Case Study #3: Efficiency & Retention Rates Tripled Using Integrated Outsourcing Model Innovative and Lean Laboratory Management
    9. 9. Highly Trained and Experienced Staff Leverage New Technologies and Operating Processes Identify and Follow a Systematic Approach to Development Comprehensive Development and Manufacturing Strategy Innovative and Lean Laboratory Management Superior Scientific and Technical Leadership … for Pharmaceutical, Consumer and Device Companies Analytical & Product Development Services : Summary Discovery Development Manufacturing cGMP cGMP cGMP C hemistry, M anufacturing and C ontrol (CMC) Activities
    10. 10. … Keeping Development and Manufacturing Strategies on Track RPS Analytical & Product Development Services
    1. A particular slide catching your eye?

      Clipping is a handy way to collect important slides you want to go back to later.

    ×