Who We Are
Malvern Consulting Group is comprised of a team of professionals with diverse backgrounds and expertise encompassing all disciplines of product development: pre-clinical, clinical, regulatory, quality, manufacturing, and packaging.
We have achieved more than 60 approved NDAs, BLAs, MAAs and numerous 510(k)s and PMAs. Additionally, our experience includes multiple, successful, company start-ups and IPOs, so we understand the challenges and pressures you face. When you partner with Malvern Consulting Group, you are getting the experience to meet your needs in a timely and cost effective manner.
Who We Serve
There are times in every company, large or small, when additional support is needed to meet the demands of the fast paced, highly regulated environment. Our services are especially valuable to the following types of businesses:
Emerging Companies With Products In Early Stage Development: Often virtual in structure, challenges include limited manpower to move the business forward in a timely manner; gaps in clinical/regulatory expertise; significant financial constraints; need to balance investments with business uncertainty.
Companies With Products In Development: No longer virtual in structure and preparing for commercialization, challenges include limited manpower for regulatory submission and commercial readiness. There is often a need to balance investments among adding personnel, the costs of development and the expense associated with commercialization.
Investors/Venture Capital Organizations: May need specific expertise to assess potential risks; understand development and regulatory options; identify potential manufacturing, supply chain or quality concerns.
Our Passion & Commitment
We at Malvern Consulting Group are passionate about working hand-in-hand with our Clients to accelerate their success. We strive to provide outrageous service and to exceed expectations, regardless of project size.
Our commitment to you:
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Malvern Consulting Group 490 Lapp Road,
Malvern, PA 19355