How Can We Help You?

When you partner with ValSource, you partner with leaders in risk management, process validation, and continued verification. We stand with you every step of the way.

ValSource Corporate Contact Information

610.269.2808
918A Horseshoe Pike,
Downingtown, PA 19335

Mt

Microneedle & Transdermal Delivery

011

From pre-IND stages through commercialization, we have the expertise to help navigate the complex regulatory environment for microbiological control of microneedles and other novel transdermal 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.

Download Brochure

Annex 1 revision experts.

Our consultants are highly-recognized for their Annex 1 knowledge and expertise. We provide a plan forward through Annex 1 updates, today and into the future.