Regulatory Alignment & Guidelines
Testing strategies structured to support regulatory-facing biosafety and CMC data packages for biologics, vaccines, viral vectors, and cell and gene therapy programs.
Map testing scope to product type, phase, and target market
HyQure supports sponsors by connecting testing scope, method strategy, report structure, and regulatory expectations early in the project lifecycle. The purpose is not to claim universal regulatory acceptance; the purpose is to make testing data easier to defend during technical review, supplier qualification, IND/CTA/IMPD preparation, BLA/MAA planning, WHO PQ-related work, and commercial release support.
ICH Q5A(R2)
Viral safety evaluation, Viral testing, Viral
clearance, and product-specific risk
considerations for biotechnology products and
relevant viral-vector-derived products.
ICH Q5D
Derivation and characterization of cell substrates used for production of bio-technological and biological products.
ICHQ2 (R2)/ Q14
Analytical procedure validation, development, and life-cycle principles for quality-controland regulatory-facing reports.
WHO TRS978
Cell substrate characterization and viral safety expectations relevant to biological medicinal products and international procurement pathways.
FDA/EMA/NMPA-CDE
Regional expectations for biologics, vaccines, CGT, viral vectors, cell banks, CMC, data integrity, and submission documentation.
Product-type alignment
- mAbs/recombinant proteins
- biosimilars
- vaccines
- cell and gene therapy
- viral vectors
- iPSC/MSC cell banks
- ADCs
- oncolytic viruses
- RNA/LNP
Submission support
- IND/CTA/IMPD
- BLA/MAA
- WHO PQ
- Commercial Lot Release.
Competitive customer service angle
HyQure can help customers translate product type, phase, target market, and testing scope into a practical testing plan with clear reports and official reference logic.
Related HyQure services
Analytical Development & Validation
Plan a quality-driven testing package
Share product type, development phase, target market, sample type, method status, and expected report format. HyQure can help align scope, documentation, and timeline before project initiation.
Official regulatory reference links
- FDA CGT Guidances
- EMA ATMP Guidelines
- NMPA Laws and Regulations
- CDE In Vivo Gene Therapy CMC Guideline
- PMDA Regenerative Medical Products
- MHRA GxP Data Integrity Guidance
- EU GMP Annex 11
- TGA Advanced Therapies
- Health Canada Biologics / CGT Guidance
- MFDS Advanced Regenerative Medicine / Advanced Biopharmaceuticals
- CDSCO Biologicals Guidance
- HSA CTGTP Guidance Documents
- WHO TRS 978 Annex 3 Page
- ICH Quality Guidelines