BioSciCon is an acronym for Biomedical Science Consulting, Inc - the company that was incorporated in 1996, by academicians who wanted to develop one of their discoveries into products for the benefit of people. BioSciCon has started with three divisions, each determined towards specific expertise of the founders: Education, Research & Development, and Consulting.

However, since the breakthrough discovery of MarkPap biomarker resulted into a very successful development of a method for this biomarker utilization in clinical practice, the company had to focus on designing and developing new products on this proprietary MarkPap® platform technology. Throughout the years four generations of MarkPap® products were developed.

Education continued as the secondary focus with Professor Olivera Markovic teaching numerous science and health courses at major universities in the Washington Metro Area. A summary of this activity came in 2008 when Springer Science published their book, "What Every Woman Should Know About Cervical Cancer", which is now in worldwide distribution (www.amazon.com). The second edition appeared in 2010, and the updated an extended edition is expected in 2014.

In 2014 BioSciCon is upgrading and renewing its Consulting activities. Current Consulting Services are focused on Regulatory Consultancy in the field of Drugs, Biologics and Medical Devices. Two more services are introduced: Medical Writer’s Services and Translation Services.

Regulatory/Medical Consultancy

Our goal in the Consulting Business is to provide prompt, highly qualified and competent services at competitive prices. No job is too small not to be respected - no job is too big not to be challenged! We tend to build long-term relationships and partnership with clients based on mutual trust, respect and integrity. BioSciCon’s current consulting focus is on Regulatory Consultancy on Drugs, Biologics and Medical Devices. We can help in clinical study design and evaluation and provide expert support throughout the whole lifecycle of the project.

Our offering of Consulting Services include, but are not limited to:

• Assistance in the preparation of scientific and regulatory submissions to FDA
• FDA presentations, clinical protocol development, regulatory review of clinical protocols
• Assistance IND/NDA/IDE preparation and maintenance for submission to FDA
• Informed Consent, Human Subject Protection, IRB issues helping companies to resolve several ethical problems related to FWA certificates for the appropriate use of medical techniques, devices and drugs
• Briefing documents, clinical development plans, summaries on adverse events and clinical trial protocols

High level Consulting Services:

• Development of new regulatory strategies
• Special tasks, e.g., special client requests, problem solving tasks, preparation of FDA query responses
• High level QC review of regulatory documents to assure compliance with FDA requirements and guidance, providing independent external reviews
• Amendments and similar duties of senior regulatory consultancy, including manual development and journal articles preparation

Medical Writer/Science Writer Services

One problem jeopardizing the medical communication globally, as we found out, is the lack of common language – much worse, the use of common medical terms with different meanings. We found this problem even in the most praised medical literature. Having our medical education completed in Latin, before English, and understanding the value of proper usage of words and terminology, we decided to help interested clients for proper writing their ideas particularly aimed for international audience. The Medical Writer Services were developed to materialize this concept.

We offer Medical/Science Writer’s expert help in:

• Grant preparation, diverse science project preparation
• Content development of scientific meeting presentations, including platform, poster presentations, PPP presentations and video presentations
• Preparing abstracts, articles, chapters, monographs in the field of BioSciCon’s expertise
• Scientific literature search and review
• Providing editing/review, advice on draft and final scientific or regulatory documents before internal and/or external submission to assure compliance with requirements and guidance (FDA)
• Preparation of Informed Consent Forms, Human Subject Protection, assistance in obtaining FWA Certificates
• Preparation of query responses from regulators
• Preparation of training documents

Translation Service

Our interest is to help people who are less confident in English medical terminology, to get the most appropriate translation of medical information, which is not available in their native languages.
BioSciCon is offering medical on-line prompt translation services from Croatian, Serbian, Serbo-Croatian, and Macedonian to English and vice versa. It includes, particularly, but not limited to: medical information and data translations, translation of medical documents, medical records, informed consent, etc. We also offer medical writer's help for grants preparation and submission, scientific projects, regulatory submissions, preparations of presentations, abstracts and scientific papers in the area of our expertise.

Consulting Services Offered, Grouped According to NAICS Codes

A combination of educational background (MDs, PhDs), clinical and academic training (professors of internal medicine, basic medical sciences, oncology, hematology, FDA regulatory Staff College), with recent entrepreneurial experience, provides BioSciCon team members the confidence to offer consulting services in the wide area of GSA and to accept the challenge of different project solving tasks in the Government procurement requesting services from expert consultants in the industry fields cited below.

Description of Services

Program Areas