COMPANY

PharmDedict is a pharmaceutical consultancy company providing a wide range of services within the scope of business development and regulatory affairs as well as all kinds of translation services.

PharmDedict uses its expertise and network of professionals to provide consultation for all major aspects of the healthcare business paving your way to successful market entry. PharmDedict offers you an in-depth knowledge of the worldwide generic industry as well as experience in establishing new generic business in Eastern Europe thorough knowledge of the latest European pharmaceutical legislation and contacts with some of the major institutional and industry representatives.

PharmDedict can assist in all kinds of licensing deals and contracts by matching your product sourcing needs in time and territory and assuring a smooth negotiation process. We are well connected with a number of generic companies and excel in bringing together distinguished partners that provide high quality pharmaceutical products.

PharmDedict has well-established relations with reliable cGMP certified manufacturers worldwide thus offering you contract manufacturing services through various partnerships in order to improve your cost effectiveness of bulk or/and finished products manufacturing.

In the field of regulatory affairs PharmDedict's services include preparation of regulatory submissions under national registration procedures and providing assistance with national steps for MRP, DCP and Centralized applications. In addition to that we also convert dossiers into CTD from old NTA-structured contents and compile quality, non-clinical and clinical overviews, Summaries of Product Characteristics, Patient Information Leaflets and Product Labelling according to local requirements depending on the country of interest. Complying with post-approval and post-marketing requirements as part of pharmacovigilance practices is also included in the scope of services provided.

Alongside the above listed activities PharmDedict also provides translation services and legal advice to our clients. We are confident that we will meet our clients' expectations as we maintain high standard of services and work in close collaboration with professionals. At all stages of our work we appreciate the input received from our clients as it further stimulates the constant improvement of our performance.