REGULATORY AND DRUG DEVELOPMENT CONSULTING / FDA SUBMISSIONS

We provide integrated strategic, regulatory and drug development consulting on drug candidates from pre-clinical research and pre-clinical IND enabling work to IND opening and to various phases of clinical development, and to NDA/BLA filing, including the following key disciplines:

• Pharmacology and Toxicology;

• Drug Metabolism and Pharmacokinetics (DMPK);

• Clinical Pharmacology;

• Clinical Development;

• Chemistry, Manufacturing and Controls (CMC);

• Current Good Manufacturing Practice (CGMP) Compliance;

We also help clients to prepare and submit Fast Track Designation, Breakthrough Therapy Designation, and Orphan Drug Designation Requests.

REGULATORY SUBMISSIONS AND PROJECT MANAGEMENT

We prepare and review drug submission packages, including Pre-IND, IND, NDA/BLA, annual reports, and various FDA meeting information packages.

We use eCTD templates and electronic submissions in accordance with the FDA electronic submission requirements.

FDA COMMUNICATION STRATEGIES AND AGENT REPRESENTATION

We will represent our clients during negotiations with the FDA regarding drug development strategy, navigating through the FDA’s regulatory submission, review, and approval processes (from Pre-IND, IND filing, various clinical development phases to NDA/BLA submissions). Our company provides expert knowledge in the fields of toxicology, DMPK, clinical pharmacology, clinical development, CMC, and CGMP compliance, all of which we contribute to FDA communications and drug applications. We offer our expertise for all types of meetings with the FDA, including but not limited to: pre-IND meetings, end of Phase1 meetings, end of Phase 2 meetings, pre-NDA/BLA meetings, and other regulatory meetings as needed, such as Type C, Type B, and Type A meetings. We help clients to prepare and submit Fast Track Designation, Breakthrough Therapy Designation and Orphan Drug Designation Requests.

CGMP MANUFACTURING COMPLIANCE CONSULTING

We provide consulting services concerning Current Good Manufacturing Practice (CGMP) in the following areas:

• Assessing the adequacy of GMP compliance on clinic material manufacturing in different clinical phases;

• Evaluating quality management system and system-based CGMP compliance, including but not limited to:

  • Providing auditing and gap analysis services for API, OSD, sterile and biotech product manufacturing facilities, including laboratory data integrity evaluation;

  • Consulting in preparation for FDA CGMP inspections on all manufacturing sites, including biotech product manufacturing facilities;

  • Providing post-inspection response and CAPA implementation to address any deficiencies, etc.;

• Providing blue-print or facility design review to ensure manufacturing facility to be built meeting CGMP requirements.