Services

Regulatory and development support across the entire product lifecycle.

Engage LINQ for a focused strategic question, a major regulatory milestone or integrated program support from preclinical development through approval.

Preclinical / Nonclinical Development

Integrated nonclinical development strategy
Animal model and proof-of-concept planning
GLP toxicology strategy and study design
Regulatory-enabling package development
CRO selection and oversight

Chemistry, Manufacturing & Controls (CMC)

CMC development strategy
Process and analytical development planning
Specification and control strategy
Technology transfer and CDMO strategy
GMP manufacturing readiness
CMC regulatory documentation

Regulatory Agency Engagement

Pre-IND and milestone meeting strategy
Scientific advice and briefing packages
Meeting questions, preparation and rehearsal
Meeting leadership and follow-up
Regulatory risk and pathway assessment

Clinical Trial Applications & GCP

IND and CTA strategy
Clinical protocol and development-plan input
Investigator's brochure and submission coordination
GCP compliance strategy
Clinical trial start-up and regulatory support

Marketing Authorization

BLA, NDA and MAA strategy
eCTD dossier planning and coordination
Regulatory writing and gap assessment
Agency review-response strategy
Inspection and approval readiness

Post-Approval & Phase 4 Compliance

Post-marketing commitments
Lifecycle regulatory strategy
Variations and supplements
Labeling changes
Phase 4 and compliance planning

Additional capabilities

Specialized support for biologics and global-health programs.

Vaccines & Biologics

Development and regulatory strategy for complex biological products, vaccines and recombinant therapeutics.

Advanced Therapies

Strategic support for gene and cell therapy programs with integrated CMC, nonclinical and regulatory considerations.

Global Health & Market Access

Strategies that connect product development with public-sector, donor, multilateral and LMIC access pathways.