Welcome to XPhase Pharmaceuticals Inc.

XPhase Pharmaceuticals, Inc. is an international drug development and regulatory consulting company based in Toronto, Canada.

XPhase provides services to assist small to medium pharmaceutical and biotechnology companies around the globe accelerate their drug development efforts. The company is focused on providing drug development consulting services and project management services from pre-clinical to clinical proof of concept stage. XPhase analyzes client’s existing data package in the local jurisdiction and provides a rational and cost-effective drug development plan which complies with global regulatory standards.

XPhase also provides quality control and quality assurance consultation to offshore organizations for compliance with international cGMP standards.

Our technical experts have an extensive track record in assisting clients in the US, EU, Central Eastern European and Asian countries.

Our Expertise

1) Drug Development

Pre-clinical development to IND submission of new chemical entities

Formulation, analytical and manufacturing process development for both small molecule and large molecule drug candidates

Clinical development to proof of concept efficacy including study designs and protocol preparation

2) Project Management

cGMP quality systems development

cGMP audits, mock pre-approval inspections and assist in responding to observations

Regulatory strategy and support from early phases of drug discovery to final regulatory approval

Scientific advice and assistance with pre-submission meetings with regulatory agencies (e.g., US FDA, EMEA, Health Canada)

Regulatory strategy for global pharmaceutical markets, including dossier preparation, assessment and gap analysis

3) Training

On-site customized training on scientific, project management, compliance and regulatory topics

Organization and delivery of international conferences

Do you have any specific project issue? Click here for expert advice.

Our Senior Consulting Team