Consulting

Mission Statement

We know about the interaction of business activities and regulatory requirements of the well regulated segment of pharmaceutical and medical world. A team of experienced experts is available to support your business plans.

Or maybe you want to outsource the below mentined activities? Get in touch with us and we find a solution for you that lines up with your ideas and business.

Regulatory Affairs

• Development of regulatory strategy for the product’s life cycle

• Consideration of international regulatory requirements

• Meeting international fillings

• Plan revision as guidelines change

• Dossier/submission preparation or review and filing

• Facilitate interaction with regulatory agencies, such as in meetings, conferences, negotiations during development stages, submissions and submission approval process

• Regulatory classification of products across the areas

• Renewal submissions

• Provide expert regulatory CMC compliance advice throughout product development

• Work with the concerned regulatory authorities through the resolution of complex development issues

Pharmakovigilance

• Implementation and Maintenance of PV Systems

• Regulatory Compliance

• Trainings

• Pharmacovigilance Audits

Quality Management

• Implementation and Maintenance of QA Systems

• Training

• Document Templates

• GxP and QA Audits

Business Development

• Market Feasibility Study

• In/out Licensing

• Foundation of local branches/representative offices

• Identification of distributors and business partners