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Specialty Consulting
005 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.
005 Specialty Consulting services
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Microneedle & Transdermal Delivery
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.
- 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.
At
Advanced Therapy Medicinal Products (ATMPS)
ValSource consultants have unparalleled expertise to help navigate the complex regulatory environment of ATMPs. 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 development and manufacturing.
- CDMO Support
- Quality Risk Management
- CMC/Regulatory
- Manufacturing Science & Technology
- Facility & Equipment
- Contamination Control Stratedy
- Quality Systems & Inspections