Services

Drug & Biotechnology Development, LLC (D&BD) provides a focused approach to the pharmaceutical and clinical development of drugs, devices and biologics for regulatory submissions.  D&BD has extensive experience with all phases of product development, including pre-clinical, clinical (Phase I-IV), CMC (analysis, formulations, process, production), outsourcing, CRO oversight and regulatory interactions, document preparation, review and filings.
Our services include:

Pre-Clinical and Clinical Development

1. Formulating pharmaceutical product development programs and plans
2. Legal strategies and patent development
3. Clinical protocol development and study designs for phases I through IV
4. BA and BE clinical approaches and protocol development
5. PK / PD modeling and simulation
6. Medical writing
7. Biostatistical and statistical approaches
8. Formulation and process evaluation
1. Small molecule synthesis to macromolecule bio-processing
2. Solutions, solids, suspensions, aerosols, transdermals, parenterals
9. Analytical / Bioanalytical approaches
10. Validation plans
11. Quality systems
12. IND preparation and submission
13. Package insert preparation
14. Organization and preparations for FDA – Sponsor Meetings including:
1. Pre-IND Meetings
2. End of Phase II Meetings
3. Pre-NDA Meetings
4. Other type A, B, and C meetings, regulatory submissions and responses
15. Construction of Standard Operating Procedures (SOPs) for product development and clinical research
16. Review business practices, opportunities and products for licensing, development, and due diligence prior to acquisition or public offering

Registration Submissions and Support
D&BD provides experience and support with the following regulatory submissions:

1. IND
2. DMF
3. Annual Reports
4. PSUR
5. NDA
6. BLA
7. PMA
8. ANDA
9. eCTD

GxP and Regulatory Consultancy
D&BD provides rapid, comprehensive and effective advice to clients on a broad range of regulatory and technical issues, including:

1. Implementation of a compliant quality management system
2. Advice on legal and regulatory issues including:
1. Patent challenges
2. Citizen’s petitions
3. Litigation
4. Assistance with responses to regulatory inspections
5. FDA 483s, deficiency letters, warning letters
6. Review of validation plans
7. Quality and regulatory audits

CRO Qualification
D&BD can assist you in your search for the appropriate contract research organization (CRO) or by performing audits on your behalf to any specified GxP standard.  D&BD can assess potential contract services for:

1. Clinical supplies
2. Production
3. Packaging
4. Testing
5. Storage and distribution
6. Validation

Preparatory regulatory audits
D&BD has assisted clients to prepare for an imminent regulatory inspection by conducting one or more "practice" regulatory audits in advance of the pending “actual” FDA, EMEA, etc. regulatory visit.  The client will receive an impartial and professional assessment of their current state of compliance with the current regulatory expectations, actions and corrective plans for non-compliant areas, procedures, training and support to successfully manage a regulatory audit.

Due Diligence Audits
D&BDassists pharmaceutical companies, investment banks and private venture capitalists in the process of due diligence for potential acquisitions, buy-ins, joint ventures and other investment projects.  D&BD performs in-depth assessment of the regulatory compliance status of companies and/or projects

Please feel free to e-mail us with your specific problem. We will do our best to assist you.