Who are we

Quality Management

Design, develop, implement and monitor quality management systems to increase our client's overall operational efficiency.

GxP Audits

А structured approach to third-party quality audits covering all areas of the pharmaceutical industry, from API to finished product including sterile medicinal products, biotech products, warehouses, and medical devices. 

GxP Training

Unique GxP training programs are built around the needs of each individual client to ensure they meet the requirements laid out in a company’s regulatory mandates, whether they come from the FDA, EMEA, or other regulatory bodies.

Project management

Supporting pharmaceutical companies in complex projects to optimize existing manufacturing facilities or new start-ups. We work with our clients to tailor an innovative and efficient solution that can help to meet their objectives.

Outsourcing

Supporting our customers with the management of all external supplier quality aspects, be it certification development, product testing, or inspection service delivery. We aim to ensure that our customers are work with reliable and qualified external suppliers.

Consultancy

Implementing best practices that fit pharmaceutical business needs and meet the legislative requirements and compliance of global regulatory authorities. Our core competencies include Regulatory inspections, GAP analyses, and CAPAs resulting from regulatory agency inspections. We also provide risk management and problem-solving services to help our clients meet their business goals.

Qualification

Supporting all site-specific requirements, including process equipment, utilities, and building qualifications-URS creation and maintenance support, DQ, FAT, SAT, IQ, and PQ protocols.

Business Development

Through our business development services, we seek to partner with partners who have the capacity and experience to help our clients reach their global market potential. We provide a range of services designed to support this drive, from strategic services, through to marketing support.

CMO Selection

Supporting in all stages of the EU testing and QP release services, including setting up projects, building test cases and test plans, requirements gathering, manual testing, preparing test documentation, and reporting of findings.

Digital Marketing

We aim to help pharmaceutical businesses achieve their marketing and business goals. Our approach is methodological and tailored to each client's specific needs. Whether it is increasing website traffic, generating leads, or improving brand awareness, we have the skills and experience necessary to help your business succeed.