Step-In Pharma SRL has qualified expertise in:

Regulatory Affairs

Pharmacovigilence

Clinical trials

GxP/ Other quality systems (ISO 9001, ISO18001,ISO 13485, others)

Step In Pharma SRL

• is keen to work   with companies who are in need of expert advice. 
• has the role to tell   you the current legislative/regulatory and quality standards and what you need  to do to meet them. 
• is able to explain why you need   to do what needs to be done,
• help you to generate data   which will successfully meet the requirements.
• help you to set up the right   quality systems covering the entire product lifecycle (drug development, supply and regulatory control of new and existing pharmaceutical products/medical devices, storage and distribution

Step-In Pharma SRL senior level personnel (company staff
and recognized local experts in contractual partnership)

• are highly skilled, with experience in the multinational arena
• have consistent and professional expertise in various technical areas for medicinal products and medical devices (regulatory affairs, pharmacovigilance, clinical trials, quality assurance, quality control)

Step-In Pharma

• has a totally transparent approach with the clients
• we work with you by sharing our expertise and transferring knowledge to you
• enable you to understand how important is to have a standardized Quality Management System in an organization
• provide ready to use documents and presentation kits, helping you to save your valuable time and increase awareness of your organization
• work discreetly and professionally, focusing only on the task and protecting the integrity of confidential information.

• Are you a new, a small company or an established one looking for increasing your business?
• Are you a pharmaceutical company or a service supplier for a pharmaceutical company (producer, warehouse, distributor, etc) willing to implement a Quality System or upgrading the existing one?
• Are you facing an imminent inspection from regulatory body?
• Do you need qualified assistance in revising/upgrading your internal processes/procedures (Standard Operating Procedures)?
• Do you need technical assistance in preparing a Site Master File, Pharmacovigilance Master File, Quality Manual?