1 Feb 2023

Checklist Clinical Manufacturing

PDF 2.5 MB

Get your product to the clinic with confidence

The shift from preclinical to clinical development is a critical step in the development of your drug product.

During this transition, you not only have to significantly upscale production of your product, but also make many strategic decisions that will lay important groundwork for your regulatory submission, commercial production of your product, and many other key components of your products life-cycle.

This eBook will help you build a plan that not only streamlines your products path to the clinic but also sets you up for long-term development and market success - starting with a proven 6-step process for filling your critical clinical batch.

Content provided by our supplier

Vetter Pharma-Fertigung GmbH & Co. KG

  • DE
  • 2015
    On CPHI since
  • 3
  • 5000+
Company types
Contract Service
Primary activities
Contract Manufacturer

Other Content from Vetter Pharma-Fertigung GmbH & Co. KG (28)

  • News Vetter joins United Nations Global Compact Network

    Vetter (Ravensbury, Germany), the aseptic filling and packaging CDMO has signed up to the UN Global Compact Network. 
  • Brochure Bringing your drug to the market

    As experienced partner in injectable manufacturing, we support you every step of the way, guiding your product through development, regulatory approval, launch, market supply and life cycle management, accelerating your ability to bring new drugs to market
  • News Vetter’s Clinical Facility Demonstrates Success with Five Client Products Now on the Market

    With the increasing drug development for novel therapeutics, a growing number of pharmaceutical and biotech companies are seeking clinical manufacturing partners to help meet the demand for complex fill-and-finish solutions. And, while the stages of early drug development are challenging, Vetter, a globally leading Contract Development and Manufacturing Organization (CDMO) is committed to addressing this challenge by offering comprehensive expert manufacturing services for clinical trials and supporting their customer products' path to commercialization. A testament to this commitment is evidenced by the success of its Skokie facility which has already contributed to bringing five new customer products to market since it began full operations in 2011, with another four expected to launch in the next months. 
  • Brochure Comprehensive support for your injectables

    We look at your project from every angle to help you find answers that work – answers that support your goals for quality, reliability, innovation, safety, and efficiency. When you partner with us, we integrate with your team to design and implement a personalized plan for success in a shifting global marketplace.
  • News Strength in sustainability: Vetter wins gold in EcoVadis ranking

    Vetter, a globally leading contract development and manufacturing organization (CDMO), achieved gold status in the renowned, independent EcoVadis sustainability ranking. With 72 points out of a maximum of 100, the pharmaceutical service provider significantly increased its score compared to the last evaluation and is now among the top five percent of all participating companies in the industry.
  • Brochure Vetter Packaging Solutions

    Delivering your product’s potential
  • News New fully automated Vetter warehouse expands storage

    Vetter, a globally leading contract development and manufacturing organization (CDMO), announced the commissioning of a new warehouse designed to help meet increasing customer market supply demands. 
  • Brochure Vetter Commercial Manufacturing

    Delivering results across the production chain
  • News Vetter drives its sustainability campaign forward

    Vetter, a globally leading contract development and manufacturing organization (CDMO), has in place a comprehensive sustainability strategy that has made it a pioneer in this energy-intensive industry. 
  • Brochure Vetter Corporate Brochure

    From clinical development to commercial production
  • News Vetter’s new clinical manufacturing site now officially authorized

    Vetter Development Service Rankweil receives manufacturing authorization

    - Important milestone reached for the new site

    - Additional filling capacities for early-stage clinical development

    - First customer audits already completed
  • Brochure Vetter Development Service

    Supporting your compounds success
  • News Vetter’s extraordinary performance sweeps the board at the 2022 CMO Leadership Awards

    Winning all six core categories and three champion ratings validates Vetter as a trusted partner

    - Vetter’s high-level performance further substantiates its dedicated performance in customer-critical services

    - Results affirm the approach, vision, and strategy of the company’s daily work for customers

    - High ranking is further affirmation of customer experiences in working with Vetter as a strong and reliable partner

  • Brochure Comprehensive support for your injectables

    Build them together with Vetter.

    Succeeding in today’s global pharmaceutical and biotech markets requires flexible thinking and precise manufacturing. No matter what phase of development your injectable product is in, we have solutions that can open new doors, shorten lead times, and solve complex challenges. At Vetter, we look at your project from every angle to help you find answers that work – answers that support your goals for quality, reliability, innovation, safety,and efficiency. When you partner with us, we integrate with your team to design and implement a personalized plan for success in a shifting global marketplace.
  • News Vetter publishes first sustainability report

    Pharmaceutical service provider integrates sustainability goals into its corporate strategy
  • Brochure Vetter at a glance

    We’re a global expert in aseptic filling and packaging of injectable drug products – learn more about us.
  • News Vetter Achieves a Three-Peat in Winning the Best Managed Companies Award

    The company’s ongoing focus on strategic execution and sustainability sealed the win. 
  • News CPHI Trend Report - CDMO Opportunities in the Chinese Market

    Opportunities for contract development and manufacturing organisations (CDMOs) in China continue to grow but many questions remain over what the future of the sector will look like in the world's second largest pharmaceutical market.
  • Video Customized packaging development

    We offer a wide range of packaging services and injectable delivery systems that can be tailored to your product’s specific needs and optimize end-user convenience.
  • News Vetter further expands its development service with new site in Austria

    The CDMO responds to the growing demand for complex fill and finish solutions.
  • Video V-CRT®️ - an integrated cleanroom concept

    This innovative concept is based on the central idea of fully automated decontamination of the entire cleanroom, including RABS, using hydrogen peroxide (H2O2). V-CRT®️ is a two-barrier system that minimizes the risk of contamination and offers a number of advantages over existing concepts.
  • News Vetter wins Axia Best Managed Companies Award

    Judges describe the CDMO's "exemplary management" as a role model for other medium-sized companies.
  • Video Corporate Video

    Comprehensive support for your injectable | Aseptic fill finish services at Vetter.
  • News Vetter aligns development service laboratory portfolio under one roof

    Bundling of competencies optimizes workflow of customer projects.
  • Video CMO Leadership Awards 2022

    Vetter wins the 2022 CMO Leadership Awards | Statement Sr. Vice President Carsten Press
  • News Vetter works towards a sustainable energy supply

    All German sites of the pharmaceutical service provider will be supplied with green electricity.
  • Video Oskar Gold - Market Developments

    Market developments and multifaced impacts (Interview with Oskar Gold)
  • Podcast Podcast: Drug Development-The Next Frontier for CDMOs?

    The increasing demand for the manufacturing of highly complex biologics has driven many biotech and pharma companies to seek alliances with CDMOs. A qualified CDMO can help to understand business priorities, develop strategies to save time and costs, and provide regulatory guidance. This, in turn, means that CDMOs must have the right approach in place to fulfil high-quality requirements and have the right manufacturing technologies and capabilities in place. The complexity of CDMOs’ work will increase with new markets, demographic changes, and new demands in the clinical production of pharmaceuticals. This podcast was originally aired as part of the CPHI Festival of Pharma.