Beijing, China

Email:

customer@cnphds.com

Phone:

+86-10-84466227

+86-10-84466228

+86-10-84466229

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Medical Writing & Quality Review

Rely on familiarity with current industry practices and regulatory requirements, our medical writing and editorial team is dedicated to perform document management, medical writing and quality review to ensure content integrity and consistency with customer and/or regulatory submission standards.

 

Our Medical Writers work closely with Clinical Data Management, Biostatistics and Regulatory Affairs departments to provide high quality compliant documentation in an efficient and timely manner.

 

Our Medical Writing and Quality Review services include, but are not limited to:

l   Protocols

l   Clinical Study Reports

l   Patient Narratives

l   Investigator Brochures

l   Patient Information and Informed Consent Forms

l   Clinical Development Plans

l   CTDs and eCTDs

l   Summary of Product Characteristics/Product Information Leaflets

l   Medical Communications (Manuscripts, Abstracts and Posters)

l   Quality-Review of Previously Written Clinical Documentation

 

Quality Control Medical Document Review Processes

All medical documents written by PHDS are subjected to rigorous internal reviews, fact-checking and quality control procedures to ensure compliance with structure guides and regulatory guidelines, ensuring the highest quality.

 

CMC documentation

Working with our clients' manufacturing facilities, PHDS provides regulatory guidance in setting specifications, method development and validation as well as conducting stability studies. We can also identify contract manufacturers and arrange contract laboratory services. 

Our regulatory affairs department supports our clients' chemistry, manufacturing and controls (CMC) development to: 

 

1.    Identify contract manufacturers specific to a client's needs

2.    Manage the contract manufacturing and/or analytical testing of the drug substance and/or drug product

3.    Provide regulatory guidance in setting appropriate manufacturing specifications, in method development/validation and in the conduct of stability studies relevant to the clinical phase of development

4.    Consult on GMP training and GMP feasibility audits as well as standard operating procedure writing

5.    Coordinate with a client and contractors involved to ensure all development work is performed properly and in a timely manner

6.    Prepare quality/CMC summaries for regulatory submissions

7.    Cooperate with regulatory authorities regarding chemistry and manufacturing issues