01
Supplier qualification & audit preparation
Define your supplier-review scope and the product, site and traceability information required. We coordinate evidence collection, track document gaps and clarify responsibilities with the manufacturer.
Evidence · Scope · Documentation
Regulatory & Audit Support
A clear documentation pathway for your supplier qualification and product review, with responsibilities and evidence confirmed case by case.
02
Product-specific regulatory evidence
We coordinate available product documentation and relevant analytical evidence. Any risk assessment or additional testing is evaluated against the exact product, intended use and agreed project scope.
03
Customer quality-team review
We cooperate with customer SQQs and organize appropriately sanitized supplier and product evidence for QA or QP desktop review. Document issuers and batch traceability remain clear; the customer quality team retains final acceptance and release decisions.
RSM technical support under CDA
For selected regulatory starting materials (RSMs) and advanced intermediates, a confidentiality agreement (CDA) and project feasibility review can establish the scope for route overviews and critical quality-control parameters. Detailed routes and customer-specific technical packs are shared only within the agreed confidentiality and approval scope.
Residual-solvent, metal and other targeted analytical data can be evaluated against the product, intended use and quality agreement. Regulatory submission support is assessed for collaborative projects; document availability does not constitute regulatory acceptance.
From request to confirmed scope
Include the product name or CAS, your specification, the document purpose and any relevant review requirements. We will confirm available materials and next steps by email.
Manufacturer documents and any external analytical reports are reviewed within the agreed project scope. Additional testing, consultation and sample evaluation are planned with the relevant provider; methods, fees, timelines and deliverables are confirmed before proceeding.
ICH Q7: responsibilities within the applicable scope
ICH Q7 Chapter 17 addresses agents, brokers, traders, distributors, repackers and relabellers. We use the relevant scope to structure discussions on supply-chain information, documentation and traceability. The customer quality team determines applicable review and release requirements for its product and jurisdiction.
Patent Notice
Supply is reviewed against the destination, patent status and intended use. Products are not offered where the transaction would infringe valid patents or supplementary protection certificates. Where applicable, regulatory-development activities may fall within the Bolar exemption under Article 10(6) of EU Directive 2001/83/EC, as amended by Directive 2004/27/EC, or 35 U.S.C. § 271(e)(1). These provisions have specific conditions; research use alone does not establish an exemption. Buyers must confirm applicable requirements for their jurisdiction and project before ordering. Commercial supply in protected territories requires an applicable legal basis.