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Microneedle & Transdermal Delivery
ValSource consultants have expertise to help navigate the complex regulatory environment for microbiological control of microneedles and other novel transdermal products.
For efficient product development, controls must be established early as they are critical to the timely and successful navigation of the CGMP pipeline. Our experts have been directly involved in the approval of Phase 1-3 products and have held esteemed positions as microbiology experts in the US FDA Transdermal Working Group. From pre-IND stages through commercialization, ValSource is able to help.
An Emerging Field
Microneedles and other novel approaches to drug delivery without the use of traditional parenteral applications are an exciting area of development. The public health implications and patient satisfaction advantages will result in a remodeling of the current drug manufacturing and drug delivery paradigms. While significant progress has been made on the development of these products, there are still regulatory and product development challenges that must be addressed for a successful marketing authorization application.
Industry Experts
ValSource consultants have more than 40 years of combined experience in US FDA CGMPs for sterile and nonsterile pharmaceutical products including CDER, CBER, CDRH and combination products. Our experts have extensive experience both reviewing and approving Phase 1-3 novel transdermal products. Our consultants reviewed the very first submission for marketing approval of a microneedle product to CDER (recommended approval for microbiological controls). Our team was also responsible for establishing the microbiological standards for these (and other) paradigm shifting pharmaceutical products.
Ways We Can Help
Identifying appropriate microbial control specifications (CDER/CBER/CDRH).
Pre IND communications.
EOP2 meetings and planning for commercialization.
Negotiating specifications/release testing.
Document preparation.
Generating product-specific microbial data.
Applying USP methods/suitability studies.
Method development/validation.
Marketing submissions.
Specialty Consulting
Expert advice when you need it most. ValSource is available to help solve the complex issues surrounding regulatory expectations for control strategies and assist with regulatory communications beginning with initial developmental stages through commercialization.
ValSource consultants have unparalleled expertise to help navigate the complex regulatory environment of emerging therapeutics and delivery systems. We provide full services for key challenges including employing a science driven, risk-based approach to ensure success. Our consultants are widely known as thought leaders on ATMP and transdermal product development and manufacturing.