Preclinical Study

Beijing, China






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CMC Regulatory Documentation

The ultimate success of your development project relies on a successful dossier submission. On this ground, PHDS provides you with comprehensive regulatory CMC dossiers and other regulatory documentation submission services. We have the capabilities to write and compile comprehensive CMC regulatory packages for IND/CTA and NDA application. By partnering with PHDS, you benefit directly from our extensive knowledge of the CMC regulatory environment and our years of experience in directly engaging with regulatory agencies. Our project management experience and high level of prior experience with our clients add tremendous value to your development program.

We offer you CMC regulatory documentation services as part of a full development service package or as a stand-alone service. Our extensive knowledge and experience also enables us to provide you with CMC regulatory strategy and consulting services.

From API, preformulation, formulation to dossier services, PHDS is the one you can trust and definitely would benefit from.

Capabilities designed for your success include:            

Preparation of CMC documents for inclusion in regulatory dossiers, including coordination, writing and compilation

l  Investigational Medicinal Product Dossiers (IMPD)

l  Investigational New Drug Applications (IND)

l  Quality Overall Summaries (QOS)

l  Clinical Investigator Brochures (CIBs)

l  Integrated drug development reports

l  Release testing monographs for APIs and drug products

l  Interaction with other disciplines such as toxicology and drug metabolism to ensure consistency of dossier sections

l  Review of technical CMC documents either authored in house or as a service to increase your probability of success with the regulatory agencies

l  Consultation and response to questions from agencies

²  Responding to regulatory CMC questions from global health authorities

²  Preparation of position papers and responses for potential regulatory questions

Drug/Biological Dosage Formulations

PHDS has extensive experience in all types of drug/biological dosage formulations, as follows:

l  Oral dosage formulations including tablets, capsules, pellet, oral liquid, drops,

l  Topical dosage formulations: including topical creams/ointments and suspensions, transdermal patches, nasal and inhalation products, etc.

l  Injection formulations: intramuscular injection (MI) and intravenous injection (VI)

l  Blood products

l  Gene therapies, somatic cellular and tissue therapies, vaccines and combination products (biologic-drug and biologic-device)