Regulation of tissue and blood-derived products—GTP compliance, quality testing, and local marketing approvals
Design and manage RMP, REMS, aRMM, and ETASU programs that meet local authority expectations and mitigate risk
Regulatory guidance for radiopharmaceuticals—CMC, radiation safety, and local approvals for imaging agents
Implement and audit QA/QMS—ISO 13485, 9001, and local conformity assessments for continuous compliance
Compliant promotion—health claim review, KOL management, and local regulatory alignment across digital and print
Accredited GxP, ISO, and regulatory training programs that keep teams certified and locally compliant
Market-access experts—HTA dossiers, pricing analytics, and local reimbursement submissions for faster uptake
Label and IFU creation, translation, and artwork validation against local and international regulations—market-ready
Traditional herbal product dossiers, safety data, and quality submissions for local market approval and global expansion
End-to-end GxP audits, SOPs, and training to maintain local compliance across GCP, GLP, GDP, and GVP operations
Fast-moving consumer goods compliance—labeling, safety assessments, and local market-entry strategy for any category.
SaMD and digital therapeutics expertise—IEC 62304, AI & ML validation, and local clearance pathways
Strategic guidance for combo products—risk, usability, and local submission pathways worldwide.
Cell & gene specialists manage local ATMP trials, manufacturing control, and approvals in all major markets.
AI/IT engines automate local regulatory tracking, submissions, and lifecycle management for life-science firms worldwide.
Local and global compliance for agrochemicals, seeds & fertilizers—dossiers, authority liaison and approvals across all markets.
Specialized legal counsel for life-science regulation, contracts, audits, and NRA dispute resolution with local insight.
Trusted local Authorized Representative/Agent enabling market entry, vigilance, and labeling compliance in every jurisdiction.
Local biosimilar experts deliver comparability, strategy, and submission support for rapid approvals across health authorities.
Navigate biotech regulation—IND/CTA prep, local GMP compliance, and registration for recombinant proteins, biologics, and more.
Local cosmetic compliance—safety assessment, PIF, claims review, and Responsible Person solutions for fast launch.
Complete CMC docs, gap analysis, and lifecycle management to satisfy local and international quality standards.
Full-service CRO: protocol design, GCP trials, and local authority liaison for drugs, devices, and diagnostics.
SEND, SDTM, eCTD & IDMP conversions for research & clinical data, secure local/global submissions; XML/XPT, JSON, SAS XPT, STF, HL7 FHIR, DICOM files
Biocide compliance made easy—dossiers, efficacy studies, and local safety data for disinfectants in all regions.
Local GMP audits, remediation, and establishment registration to secure production license and compliance.
Local supplement regulation—claim substantiation, registration, GMP audits, and post-market surveillance.
Regulatory-ready design—proofed labels, pack artwork, and IFUs that meet local requirements and accelerate approval.
Vaccine regulatory strategy—clinical, CMC, and pre-qualification support with local compliance insight for faster access
Life-science IP strategy—patents, trademarks, and data-exclusivity protection in local and global markets
IVD regulatory experts handle IVDR, 510(k) notifications, and local submissions for a compliant diagnostic launch and rapid rollout
Compliance for lab instruments—ISO 13485 and local import licensing, from classification to post-market
Local Marketing Authorization Holder services—license maintenance, vigilance, and authority interaction made easy
Complete device pathway—risk classification, QMS, 510(k)/PMA, conformity assessment, and local post-market surveillance for every class
Expert medical writing—CTD modules, CSRs, and HCP materials aligned with local guidance to speed approvals
IND, NDA, ANDA, OTC, sNDA, PAS, eCTD, and local regulatory strategy guiding small-molecule drugs from discovery to launch
24/7 pharmacovigilance and local QPPV coverage—signal detection, PSUR, risk management, and safety reporting
Certified medical and regulatory translations and proofreading —100+ languages, localized and back-translated for submissions
Veterinary compliance—dossiers, pharmacovigilance, and local labeling for safe animal-health product launches