PHDS provides global regulatory affairs and intelligence services for all stages of pharmaceutical, biologic, healthcare and medical device product development. Our focus is on helping you understand and adhere to regulatory guidelines and address the clinical development and lifecycle management needs of your products.
Comprehensive Regulatory Affairs and Intelligence Services
With interdisciplinary teams and extensive internal resources, PHDS' regulatory affairs team is flexible and responsive to your needs. Our regulatory consulting services include:
● Clinical trial applications
● Medical devices
● Medical writing
● Publishing and submissions
● Lifecycle management
● Preclinical and CMC consulting
● Agency interactions
● Strategic consulting and intelligence
● Quality review
Regulatory Affairs Strategy and Meetings
PHDS' experienced regulatory professionals assist with the development of regulatory strategies and are available to lead and participate in regulatory authority meetings. With extensive expertise honed through the preparation of a vast array of successful development plans, our regulatory affairs staff helps speed your drug development investment, and ultimately get your products into China faster.
PHDS provides services for our clients, including:
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I. Clinical Development
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1.
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Clinical Trial Management （Local and Global multi-center study）
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2.
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Clinical Data Management
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Programming & Statistical Analysis
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II. Regulatory Affairs
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IND and NDA (Imported Drug) /OTC
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IND and NDA (Domestic Drug) /OTC
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Medical Device Registration (Imported and Domestic Products )
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4.
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Pharmaceutical Ingredient Registration (Imported and Domestic Products )
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5.
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Pharmaceutical Packaging Registration (Imported and Domestic Products )
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6.
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Functional Food Registration (Imported and Domestic Products )
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7.
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Novel Food Registration (Imported and Domestic Products )
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8.
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Food Additives Registration (Imported and Domestic Products )
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Cosmetics Registration (Imported and Domestic Products )
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Disinfectant Registration (Imported and Domestic Products )
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11.
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Drinking Water Device Hygiene Certificate Application
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12.
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Drug Registration Renewal (Re-registration) and Supplementary Application
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13.
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Imported Food Package Label Evaluation and Registration
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III. Training
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CRA Training
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Clinical Data Management Training
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Biostatistics Training
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4.
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Medical Writing Training
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IV. Technical Services
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Policy/Regulation Consultation
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Market Access Service
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Process Development and Modification, Technical Parameters Investigation
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4.
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Specification Development and Modification
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