- Once request for proposal is submitted, how soon we can hear back from you?
- What preliminary information will be provided to us after the first inquiry with PHDS?
- Who do the translation of the application material?
- How can the quality of application material be assured?
- If a product has been marketed outside China for long time, does it mean an easier regulatory approval by China Agent?
- Once the cooperation with PHDS begins, how and when we will be updated on the project progress status?
1. Once request for proposal is submitted, how soon we can hear back from you?
Our customer care department works closely with our project team and contract service group. No matter the lead source is from web, telephone, fax, or email, getting back to all your questions and concerns within 24 hours is the bottom line our practice is based upon.
2. What preliminary information will be provided after the first inquiry with PHDS?
Generally, based on your inquiry, we will do a thorough evaluation of your product / project. Based on our experience, a good analysis with considerations on the potential risk, resources needed, timeline, procedures, and quotation with cost break-down details will be shared with you.
3. Who do the translation of the application material?
Professional material translation and audit are taken care of by PHDS project teams. We didn¡¯t contract the translation out to the third party. First, we want to secure the confidentiality of all your product information, and our registration information as well. Second, we keep the highest professional level of the to-be-submitted material. Our translators with majors in Pharmacy, Formulation, Biology, Biochemistry and years of experience of working with oversea pharmaceutical or health organizations. They not only know the technical terms but understand the technical implications. Meanwhile, any discrepancies or translation error might lead to significant differences on technical data. Third, during translation practice, communication between you and PHDS can also help attain an error free material preparation in a very efficient way.
4. How can the quality of application material be assured?
We give the application material a double-secure system to ensure its quality and acceptability by China Agency. Once the application material is finished by project team, the whole set of material, as our internal normal practice, is always assigned to the second party, our inspection group, for ¡°second pair of eyes¡± examination and validation. Any inconsistencies, errors will be sifted through during this procedure. Beyond that, before submitting the application material to the Agency, we also organize PHDS¡¯ expert panel meeting to double check the document. With the aid of our exclusive experts¡¯ long-time industry and regulatory compliance experiences, we render the material full-scope qualifications
5. If a product has been marketed outside China for long time, does it mean an easier regulatory approval by China Agent?
Not really. Although, being compatible with ICH guideline, China regulatory policies sometimes set narrower limits for the technical requirements. That is the reason that why many of our clients (manufacturers or distributors) initially believed their popular products can get approval in China easily, but ended up with coming to us for ¡°secret weapons¡± to help rescue their products that had been stuck in dilemma for months or even years.
Our people with piles of successful cases behind each of them, and with good skills of communicating with local agency or authorities, are able to predict the potential risks even before the project starts. As risks are identified so early, problems can always be circumvented in a creative and smart way.
6. Once the cooperation with PHDS begins, how and when we will be updated on the project progress status?
PHDS pays big attention on communication with our clients. On a regular basis, we generate progress report and share with our clients for updates. In the meanwhile, a very active information exchanges are taken place between the focal contact persons of each side. Telephone conferences can also be called up whenever necessary. We always believe the spirit of cooperation and the convenience of communication can make impossible possible. While providing you our best professional service, we are never satisfied until you are.
For any other concerns or question, please don¡¯t hesitate to contact our customer care department at customer@cnphds.com or dial 86-10-84466227/28/29.
