Get a Smart Strategy For Your Commercialization in China
HEASLICEN is a specialized regulatory consultant firm focused on pharmaceuticals and dietary supplement in China. We aim to support and accelerate the marketing authorizations and ensure the regulatory compliance in China.
Pharmaceuticals
Biologics
Biosimilars
Herbals
Dietary supplements
Expert in Pharma Regulatory Compliance to Accelerate Your Market Access to China.
Heaslicen is a specialized regulatory consultant firm with extensive experience in pharmaceutical regulatory and medical consulting from early development to commercialization and beyond.
- Reduce regulatory non-compliance risk in China
- Accelerate access to market
- Access to deep scientific and industry knowledge
- Reach objectives&milestones quickly and efficiently
- Avoid Unnecessary costs and delays
- Harvest agency’s authentic opinions
Our deep expertise can Offer Comprehensive and Trusted Services
Start Your Regulatory Strategy with Our Experts
Heaslicen is comprised of senior regulatory experts with extensive NMPA experience to help our clients to handle the entire regulatory process. Our expertise area across CMC, non-clinical, clinical, biostatistics, marketing, post-authorisation, etc. Our dynamic, multi-disciplined, creative team have already been the trusted partner for many global clients and we are heartfelt proud of our achievements.
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We’ll Ensure You Always Get the Best Guidance.
Our deep expertise across pharma Pre-Authorization to Post-Authorization in China.
Dedicated in win-win collaboration with you.
Regulatory Affairs
Gap Analysis | Strategy | Intelligence | Dossier Creation | eCTD | Submission | Tracking Agency Meetings | Label | Due diligence | Local Agent | Post Approval Management
Medical Affairs
Clinical and non-clinical Overview | Clinical and non-clinical Summary | Clinical Protocol ICH Compliance CSR | Investigator Brochures | ICF | Medical Agency Responses | PIL
Quality&Compliance
Local Audit | Validation | GXP | Quality Assurance | Tech Transfer
Pharmacovigilance
RMP | PUSR | DUSR | Literature Monitoring | Benefit-risk evaluation reports