Dar Pharma - Clinical Trials Management,Clinical Monitoring & Research Training

 Pharmaceutical Products & Services

Dar Pharma – Our Services

Clinical Services, Phase II-IV

DAR PHARMA staff delivers integrated and effective planning and implementation from protocol design through post-market surveillance. Besides contracting clinical services, when you choose DAR PHARMA, our team supports your process with attainable solutions and specific clinical capabilities.

Clinical Trials Management

Dar Pharma supports your clinical study programs with:

• Preparation and review of clinical trial applications and notifications
• Effective communications with regulatory authorities
• Maintenance, updating and filing of documents and other correspondence
• Import and export licenses and permits
• Review of labeling for clinical trial materials
• Review of protocol packages
• Assistance with ethics committee approval
• Training

Clinical Monitoring

Throughout the development of your project, DAR PHARMA offers the singular focus of a dedicated team for a consistent and effective interaction with study sites.

Dar Pharma staff has experience in the following fields:

• Internal Medicine
• Cardiovascular
• Oncology
• Anti-infective
• SNC

Clinical Research Training

DAR PHARMA provides tutorial instruction, as needed, to the clinical research personnel involved in clinical trials, so participants develop their skills with hands-on activities that provide them with an experienced guidance through the learning process.

Training Programs:

• GCP training based on basic module.
• GCP's training advanced Clinical Investigation based on GCP's advanced module.
• Regulatory Process for Clinical Investigation in Mexico.
• Ethic Committees and their function on the Clinical Investigation process.

Regulatory Affairs

Dar Pharma's regulatory affairs staff provides you with regulatory consulting and advice for Mexican Ministry of Health dossier submission; assessing documents and providing support in Pharmaceutical development, according to Mexican and international guidelines.

• Clinical Trial Approval
• Preparation and management of Marketing Authorization Applications in Mexico and New Drug
• Applications-like (New Products Registration) and their maintenance
• Experienced guidance in setting appropriate specifications, method development and validation of stability studies for successful Chemistry, Manufacturing and Control for submissions.
• Clinical trial applications related to New Drug submission and maintenance.
• Compliance audit services.

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	Dar Pharma
	Tlacoquemecatl 123-400 Col. del Valle, Mexico City 03200 Mexico
Tel.	+52 55 5335 0349
Fax	+52 55 5559 1934