CandidPharm · Ningbo Candid Pharmaceutical Co., Ltd. · 宁波嘉安药业有限公司
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Quality & Compliance

CandidPharm connects technical sourcing with quality coordination: product requirements, supplier qualification, batch document review and export preparation. Each step gives your team a clear manufacturing source, documented specification and traceable evidence for its decisions.

Quality coordination in practice

Four connected responsibilities, from the manufacturing source to shipment documentation.

Technical sourcing with clear manufacturing responsibilities

CandidPharm coordinates specialized partner manufacturers around your product requirements. We clarify the manufacturing source, specification and document responsibilities; batch COA and SDS are issued by the manufacturer.

We coordinate supplier qualification

We collect manufacturer and product information, organize your qualification questions and coordinate responses. The review connects each document to its issuing site, product and applicable scope.

We collect and check the batch documents

For each shipment we obtain the batch document from the manufacturer and check it against the specification agreed with you before the goods leave. If a result falls outside what was agreed, you hear it from us before shipment, not after.

We handle export documentation

Packing, shipping documents and the paperwork your destination requires are prepared per order, and are confirmed with you and with the forwarder before dispatch.

Define the manufacturing site, product, intended use and review criteria with us. We organize the corresponding evidence and identify any outstanding questions for follow-up before the transaction scope is confirmed.

TECHNICAL REVIEW & TRACEABILITY

Align the evidence with your review

External analytical coordination

We coordinate external testing requests for structure, purity, impurities and stereochemistry. Suitable methods may include NMR, HR-MS, chiral chromatography or HPLC/GC. Method suitability, sample requirements, laboratory reporting scope and availability are confirmed for each proposed commission.

ICH Q7 Chapter 17 as a reference

Chapter 17 addresses agents, brokers, traders and distributors, including traceability and information transfer. We use these topics as a reference when discussing applicable source, batch and document workflows for your product.

Product-specific regulatory review

We cooperate with your supplier qualification questionnaire (SQQ), prepare reviewed and appropriately sanitized technical packs, and coordinate batch evidence and third-party analytical reports for QA or QP desktop review. For nitrosamine or other risk questions, we confirm the available assessment evidence and any further testing requirements for the selected product. Your quality team and responsible QP retain final acceptance and release decisions.

Read the ICH Q7 guideline

Documents available on request

These documents are issued by the manufacturer, and what can be provided depends on the product and the manufacturer. Use the button in the last column to ask for one: it opens the inquiry form with that document already ticked.

DocumentPurposeIssued byHow to request
Certificate of Analysis (COA)Shows the tested results for one specific batch against the specification agreed with you.The manufacturer, per batch
Safety Data Sheet (SDS / MSDS)GHS-format safety information used for handling, storage, packaging and transport decisions.The manufacturer

Need something that is not in this table, for example a statement required by your own quality system? Ask for it in the "other documents" box of the inquiry form. We coordinate manufacturer files, laboratory reports and our reviewed technical materials, confirming the issuing party and available scope for your product.

Patent & compliance notice

Where a product is under patent protection, the position below applies to any enquiry, quotation or order.

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.

Export, import and end-use rules differ by destination. Tell us the destination country and the intended use with your enquiry so we can check what applies before quoting.