Partnering opportunity

Romanian medical and science writing company providing professional medical writing services for the development of scientific documents is searching for partners in the frame of an outsourcing agreement

Summary

A Romanian company, specialized in writing professional medical and scientific documents, offers its services in the frame of an outsourcing agreement. An experienced staff of specialists in medicine, pharmaceutics, chemistry, biology, biotechnology, nanomaterials, drug-delivery, highly proficient in the use of the English language, are ready to cooperate with partners from abroad.

Partner sought

Type of partner sought: companies interested in establishing partnerships to pharmaceutical companies and CROs, that needs, due to lack of capacity, to outsource the writing of medical regulatory documents or scientific manuscripts. The medical and scientific documents are prepared in a highly collaborative process within tight timelines. Role of partner sought: the partner provides the primary documents to be worked out by the company. During the first meeting, a start-up meeting agenda is elaborated, so every aspect of the client requirements to be specified and followed. The partner is involved in the evaluation of the elaborated documents, directly or through an authorized reviewer. The documents are written are reviewed for compliance with existing regulatory policies.

Description

The Romanian company is a medical and science writing company providing professional medical and writing services for European pharmaceutical companies, Clinical Research Organisations (CROs), as well as academicians worldwide. The company started its activity in May 2019 as a start-up, headquartered in western Romania. Based on the industry experience and regulatory interactions the company is able to prepare a diverse range of medical and pharmaceutical documentation including: Pre-marketing documents: - Clinical overview – a document that evaluates the safety and the efficacy of the new medicinal compound in humans, - Non-clinical overview - a document that evaluates the safety and the efficacy of the new medicinal compound in animals, - Risk Management Plan - a complex regulatory document that is required in the European Union as part of a medicine's approval process. Post-marketing documents: - Addendum to clinical overview: a document that collects all cumulated effectiveness and safety data related to a medicinal product since marketing authorization or its last renewal, in order to obtain a new renewal for any medicinal product. - Addendum to non-clinical overview: a critical discussion as part of the renewal application, supporting the benefit-risk re-evaluation for the product, taking into account any new non-clinical data since the initial marketing authorization or the last renewal. The regulatory writing documents are prepared according to national and international regulations and the principles of the International Council for Harmonisation (ICH) guidelines. The company also provide the following services in life science: - Literature search - Synopsis writing - Manuscript writing - Preparation of structured abstract from posters - Preparation of slide deck for oral presentations at various conferences. The company’s experts have diverse scientific knowledge (in chemistry, biology, biotechnology, nanomaterials, drug-delivery, and related fields), extensive experience of pharmaceutical development, and international professional qualifications such as European Medical Writing Association (EMWA) Foundation Certificate in Medical Writing or Certificate of attendance - RA Workshop: Medicinal products - Legal framework; Basis EU dossier requirements; Basic GMP requirements; GMP and RA interfaces. The staff includes specialists from Ph.D. students to university professors, from pharmacists to physicians. All our experts are highly proficient in the use of the English language, the lingua franca of life science, Intending to find new clients internationally the company is searching partners in the frame of an outsourcing agreement.

Advantages and innovations

The main activities of the company are writing medical writing documents and scientific communication, such as articles, reports, and posters. Using specialists with more than 10 years’ experience in medical and scientific writing the company can help to save time and money in pre- and post-marketing programs. The companies’ team can efficiently transform complex scientific data into meaningful, concise, and accurate reports, in formats that comply with regulatory requirements. By selecting the Romanian company as a medical writing partner can help to accelerate and facilitate the planning, coordinating, and writing of clinical and scientific communications documentation to meet deadlines, with a readability that reduces the time for review and approval. The services offered by the company have several advantages: - Accelerate approval and support continued product success through the product lifecycle. - Partnering with a single medical writing supplier with expertise in both pre- and post-approval not only can drive cost savings but can accelerate deliverables through the gained efficiency of a single team. For example, if the outsourced team that manages the client’s scientific publications is also handling the regulatory writing, they will already have a deep knowledge of the product and therapeutic area and will be able to accelerate timelines by producing the regulatory documents faster. - Adapt the offered services to client requirements

Development stage

Already on the market

Intellectual Property Rights (IPR)

Not available


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