CMC Services & Analytical Sciences

CMC Services & Analytical Sciences Capabilities

Our multidisciplinary approach combines expert product and process knowledge with a quality-first mindset to ensure Right First Time submissions across the globe.

01

Comprehensive CMC Support

Kymanox expertise extends to all phases of development and commercialization, including CMC phase-appropriate development strategies and planning for global regulatory submissions.

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02

Quality Systems & Operations Support

Turnkey documentation development, remediation support for CGMP inspection observations, and PAI support of analytical laboratories and GLP inspections.

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03

Laboratory Design & Setup

Kymanox offers design and setup of CGMP and GLP analytical laboratories, analytical & microbial method characterization, development, and validation.

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04

CRO / CDMO Selection

Kymanox offers evaluation, selection, and management of contract research organizations (CRO) and contract development and manufacturing organizations (CDMO), including technology transfer.

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Meet our CMC Services & Analytical Sciences Experts

Ryan Doxey

DIRECTOR, TECHNICAL SERVICES AND CMC

Helpful Links

Here are some of our favorite resources on this topic

FDA CMC and GMP Guidances

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ICH Standards: CTD

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ICH Quality Guidelines

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Markets That Benefit from Our CMC Services & Analytical Sciences Solutions

Combination Products

Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.

Biologics

We understand why “the product is the process” and how to implement solutions to your unique challenges.

Pharmaceuticals

Drug development is constantly evolving with new regulations and technology. We stay up to date to maintain your compliance.

Other

Our diverse experience across the life science industry, including medical device and vaccines, ensures your challenges are in expert hands.

The Kymanox CMC Services & Analytical Sciences Difference

At Kymanox we are more than consultants. We are partners with our clients and create custom solutions that meet each client’s unique needs.

Flexibility & Agility

At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.

Proven Broad Expertise

Our team of experts is focused on life sciences with extensive experience across drug and device development. No matter your challenge, we can help you conquer it.

Dynamic Project Management

A personalized approach to project management that combines your needs with our proven tools and expertise to create a custom solution for your project.

Frequently Asked CMC Services & Analytical Sciences Questions (FAQs)

Can Kymanox author CMC (Quality) Sections of my IND, NDA, ANDA, or BLA?

Kymanox has an expert staff of regulatory and technical writers who are intimately familiar with authoring the CMC (Quality) sections for all submission types. Kymanox is also well versed in preparing all sections of your submission, as well as Briefing Packages to support communications from Pre-IND through Pre-NDA/BLA.

What other documents can Kymanox author?

The comprehensive CMC support offered by Kymanox includes, but is not limited to, Quality by Design (QbD) documentation including CQAs and CPPs, Target Product Profile (TPP), and Quality TPP (QTPP), as well as Common Technical Document (CTD) Module 3 (i.e., 3.2S and 3.2P) authoring for submission of global investigational products and market authorization.

Can Kymanox handle regulatory submissions outside the US?

Yes, the Kymanox team is experienced with the regional regulatory requirements and expectations for submissions to EU, Japan, Brazil, and Canada.

Can Kymanox help with my pharmaceutical/combination product development and regulatory strategy?

Yes, Kymanox’s expert staff of pharmaceutical development scientists and drug delivery device engineers can provide a breadth of strategic development and regulatory planning services throughout the stages of clinical development and up to market authorization. Kymanox is well versed in navigating the complexities of product development to deliver and maximize the potential for commercial success. These services include, but are not limited to, the evaluation of formulation technologies and selection and optimization of drug product formulation; evaluation of manufacturing process technologies, process development, scale-up, and technology transfer; analytical and microbiological method development and validation support; technical writing of protocols and reports; evaluation, selection, and optimization primary packaging components and drug delivery systems; stability study strategy and design; and the evaluation and selection of contract organizations.

Can Kymanox help with the selection and setup of my laboratory instrumentation and equipment?

Absolutely! The Kymanox Analytical Sciences group has professionals with global experience working with a vast array of laboratory instrumentation and equipment from bench-scale to commercial-scale in the pharmaceutical, biotechnology, medical device, and in vitro diagnostic industries. We provide on-going support for all phases of development, from discovery to post-commercialization, with services ranging from research and selection of instrumentation/equipment that are best suited to your project needs, setup and qualification of instrumentation/equipment intended for GxP use, as well as troubleshooting issues with system performance and/or assay optimization.