Services

a. Contract Manufacturing

Through the years HELP SA has provided contract manufacturing services for multinational & local pharmaceutical companies. Our successful cooperation with more than 40 companies in this field ensures your product to be professionally managed all the way to the marketplace, from development to commercial manufacture.

Our know-how and manufacturing capabilities span over a large range of pharmaceutical dosage forms, both sterile and non sterile, releasing you from the burden of multiple site selection for your business needs. Additionally medical devices, cosmetics and food supplements are included in our expanding portfolio.

b. Co development / Know How

We can support you in the development and improvement of your manufacturing processes, utilizing your facilities and equipment, with advanced flexibility based on your special needs. We can help you achieve top quality and efficacy, for pharmaceuticals as well as for medical devices, food supplements and cosmetics, which are also included in our continuously expanding manufacturing portfolio.

Over the last years, in addition to the development of our own products we have been engaging in joint developments with our partners. To that respect, an increasing number of products have been developed, either together with one or more partners or exclusively for the partner.

Our expertise has allowed us to form flexible collaborations to the benefit of all parties involved. Part of this shift has also been towards the development of novel formulations, taking advantage of new excipients and formulation science. This can improve product properties, such as a more favorable release profile, better stability or improvements over the originators products.

c. Regulatory Services

The activity of Help S.A. in a variety of geographical territories has facilitated the development of a competitive Regulatory Affairs (RA) department, with extensive experience in the registration of pharmaceuticals, medical devices, food supplements and cosmetics locally & internationally.

Our Regulatory Department is currently managing more than 150 MAs in Greece and more than 100 MAs in foreign countries.

We can offer you our consulting support or full regulatory affairs services in:

• Development, update and conversion of drug product dossiers in electronic CTD format or in a specific format as per the selected country requirements
• Registration of drug products, medical devices, cosmetics & food supplements to Health Authorities
• Post-authorization activities for the management of the product licenses, including renewals, variations and notifications.