eChinaChem, Inc., the China subsidiary of Pacific Genuity, Inc. (San Carlos, California), provides an integrated...
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1. Consultation on China specific regulatory issues 2. Application for drug import licenses 3. Application for clinical trials 4. Ethics committee review 5. ANDA application with US FDA
Tigermed is a proessional team experienced in regulatory affairs.We keep close communication with local health authorities.By a comprehensive understanding of IND and NDA procedures,Tigermed is able to ...
According to SFDA's rules and regulations, our company provides the technical services of new drugs and generic drugs (chemical drugs and Chinese medicines) as well as health foods. Apart from the technical ...
New European laws have been introduced that will fundamentally affect the registration of human and veterinary pharmaceutical and biotechnology products in the near future. Amongst the changes introduced ...
Kendle's Regulatory Affairs team understands the importance of the highest quality regulatory submissions. We'll work with you to plan, prepare and complete global or local submissions and will communicate, ...
BOSOM provides a full range of biostatistical and SAS programming services for analyzing and reporting clinical trial results. BOSOM bio statistical and SAS programming services include: 1. Statistical ...
Front End Services 1. Total Project management/Develop re-sourcing and contingency plans for clinical data management 2. Monitoring and Project Management 3. Develop study design and clinical protocol 4. Development ...
We provide Product Registration services in China including pharmaceuticals, healthcare products, health food, cosmetics, and medical devices. Very Experienced Excel has an experienced registration ...
1. Dossiers Preparation 2. Application Submission 3. Drug Quality Inspection 4. Registration Progress Follow-up 5. Import Drug License Renewal and supplement
1. Independent CRA 2. Documents Preparation for NDA 3. Application Submission 4. Approval Progress Follow-up 5. Clinical Trial Approval
Investigational New Drug (IND) registration
Agent of Registration: Involving pharmaceutical product, global Trials
Registration of local manufacture and import drugs(Chemical drugs, TCM, Bi-omedical, Diagnosis agent ) applicat-ion. Registration of local manufacture and import package materials application. Registration ...
We provide New Drug registration service,pls contact with us.
The Registration Department is in charge of medical regulations and item management. contents: Registration application for drugs, biologicals, diagnostic reagents and medial devices Registration for ...
We have established at Newsummit Biopharma a highly efficient IND/NDA filing platform drawing upon our experience and expertise in regulatory filing with SFDA. We provide regulatory filing services on ...