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Regulatory Affairs
At Heaslicen, We Provide the Comprehensive Pharmaceutical Regulatory Affairs Services.
Regulatory Affairs plays a crucial role in ensuring the successful development and commercialization of drugs as they navigate the lengthy, complex and costly process of the product launches, and even after drug approval. Regulatory Affairs consultants can ensuring the pharmaceutical companies staying abreast of the changes in the legislation of drug research, manufacture, and marketing, as they act as the communication bridge between manufacturers and agencies to keep updated on the rules and regulations.
HEASLICEN’s Regulatory Affairs team can offer comprehensive services to ensure the regulatory compliance of human pharmaceutical, veterinary drugs and nutritional supplements in China. We expedite your entire regulatory submissions, from dossier development, submission, tracking, publishing to final submissions, so that to strong your product life cycle management.
● Consulting & Strategy
Our fast regulatory intelligence committed your decision making and help to optimizing your strategy frameworks.
> CMC Consulting
> Market Access Strategy
> Pre-clinical Consulting
> Drugs Regulatory Intelligence
> Nutraceuticals Regulatory Intelligence
● Gap Analysis
A dossier gap analysis can help minimize risks and ensures the acceptation of the agency and ultimately improve the approval rate.
Our fast regulatory intelligence committed your decision making and help to optimizing your strategy frameworks.
> Quality Standard Comparison
> Data Integrity Assessment
> Test Method Comparison
> Other research method Comparison
● Application & Submission
We guarantee the exact translation and ensuring timely delivery to compliance the special requirements of NMPA.
> Clinical Trial Application (CTA) /Investigational New Drug(IND) Application
> New Drug Application(NDA) /Marketing Authorization application/ Type 5.1 Application in China
> Abbreviated New Drug Application(ANDA)/ Type 5.2 Application in China
> Biologics License API/Excipients/Packaging Filing in CDE/ DMF submissions
> Post Approval Variations Application
> eCTD Publish and Validation
> Local Agent Submission
> Nutraceuticals Application
> Animal Medicine Application
● Meeting with agency
Exquisitely prepared type I/II/III meeting aim to achieve high-quality communication.
> Pre-IND / Pre-NDA Meeting
> Health Authority Queries
> EOP-1/EOP-2 Meeting
> Deficiencies Responses & Interactions
> Local experts participate in the meeting.
● Expedited Procedure
Our professional knowledge and rich experience help positioning the correct
procedure and accelerate the approval.
> Breakthrough Therapy
> Conditional Approval
> Priority Review
> Special Approval
● Due Diligence
Due diligence is a process or effort to collect and analyze information before making a decision or conducting a transaction so a party is not held legally liable for any loss or damage. Due diligence is so vital for considering a prospective merger or acquisition(M&A). Our Regulatory Affairs Team’s experience can help ensure you will not embroiled in a costly mistake.
● Sample Testing
Sample testing is a mandatory process during the agency review. Our professional team will ensure the timely submit to NIFADC in China and the exact sample amount calculation to avoid the wasting.
● Label & Artwork
HEASLICEN’s expertise dedicated to ensuring labeling and exact Chinese expression compliance in China.
> Pharma Labeling Compliance
> Dietary Supplements Labeling Compliance
> Clinical Trial Labeling
> Patient Information Leaflet (PIL) Compliance
● Post Approval Management
Detailed and accurate assessment to ensure the drug life-cycle management and the variation approval
> Marketing Authorisation Holder (MAH) Variation Application
> Factory Transfer Application
> Quality Standard Update Application
> Clinical Trial Protocol Variation Application
> Clinical Trial Protocol Variation Application
> Other Post Approval Variations
.