BioPortfolio Limited Drug and Market Development Guides

Guide to Business Plan Writing, 3rd Edition
D&MD's Guide to Business Plan Writing, 3rd edition helps companies in the life sciences industry create an effective business plan for early and mid-stage stage business ventures. Businesses in the life science industry, which includes biotechnology, agricultural technology, pharmaceutical products, health services and medical devices, face similar hurdles in the development of their businesses. These challenges are often distinct from what is faced in other non-life science based industries.

Due Diligence in Life Science Transactions, 2nd Edition
D&MD's Guide to Due Diligence in Life Science Transactions, 2nd Edition provides a comprehensive overview on due diligence and a proven path to success for professionals working in the life sciences industry. This guide includes summaries of key investigation areas and critical questions to ask during the due diligence process. Also included are checklist tools readily employable in day-to-day business operations.

Guide to Good Clinical Practice, 3rd Edition
D&MD's Guide to Good Clinical Practice, 3rd Edition updates the regulations and their respective amendments since the 2nd edition was published in 2005. The guide details the duties of the sponsors, institutional review boards (IRB), investigators, and trial monitors. Practical advice is given on the various mandates for achieving GCP compliance. The templates of forms for study audits, data integrity checks and IRB operations are included for the reader's access.

Guide to Good Facility Design 2nd Edition
Drug regulatory agencies require pharmaceutical and biopharmaceutical establishments to comply with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations. D&MD's Guide to Good Facility Design, 2nd Edition examines these regulations and details the means whereby a facility design that is in compliance with them can be achieved economically and efficiently

Guide to Good Validation Practice 3rd Edition
D&MD's Guide to Good Validation Practice, 3rd Edition is devoted to considering in greater detail the ways of complying with validation requirements at all stages of drug research, development and manufacture. The particular problems associated with the newer biopharmaceutical products are given special consideration. To complete this comprehensive guide to validation and its problems, full texts are provided of the major guidelines issued by National and International regulatory authorities, along with the relevant abstracts from the GLP, GMP, and GCP regulations. Other references include web sites for the retrieval of the text of regulations and guidelines, a list of useful publications, and of some well-known firms specializing in validation consulting.

Guide to Good Laboratory Practice 3rd Edition
D&MD's Guide to Good Laboratory Practice, 3rd Edition examines the GLP regulations in the United States and other countries in detail, and gives firm guidelines for compliance, using as a basis the GLP requirements published in the U.S.A Code of Federal Regulations, Title 21, Part 58, 2006 Edition (21CFR58). The guidelines laid down by other countries, especially members of the European Community, are based upon guidelines developed by the Organization for Economic Development (OECD) in 1980. Guidelines on safety testing and analytical methods issued by the International Conference on Harmonization (ICH) are also reviewed. Special attention is paid to the documentation and the preparations for internal and external inspections and audits.

Preparing the Common Technical Document CTD for CMC
Regulatory bodies in the US, Canada, EU and Japan accept the CTD document format when applying for IND and NDA approval. This multiparty agreement, led by the ICH Harmonization, facilitates the application process when multi-nation regulatory approvals are being sought. The ground work and preparation of the CTD is critical since it serves as the platform for regulatory filings. Module 3 of the CTD focuses on Chemistry, Manufacturing and Controls (CMC) documentation relating to substance and product quality. Providing the correct information in sufficient detail in this section will reduce delays and costs.