Regulatory and Quality

Regulatory Affairs
Creation of a regulatory strategy is critical to defining the most rapid development timeline. Good science, while necessary, is not sufficient for successful regulatory filings. The Food and Drug Administration’s requirements are rigorous, ever-changing and not always obvious or straightforward. PTR provides a full range of proven Regulatory Affairs services including regulatory strategy development, preparation of regulatory filings, and serving as your interface / representative with the FDA. In addition, Pharma Technology Resources can provide support for international regulatory filings.
»Read case studies ...
»Read case studies ...

Manufacturing Regulatory Compliance Audits
Regulatory Compliance represents an area of significant risk in the production of active ingredients, clinical supplies and commercial formulations. Managing this risk while controlling costs requires knowledgeable and pragmatic interpretation of the FDA’s Current Good Manufacturing Practice regulations and product-class specific regulatory guidance documents. Regardless of whether manufacturing is in-house or outsourced, the IND or NDA holder is responsible for FDA regulatory compliance. Pharma Technology Resources provides comprehensive auditing services, in which we identify deficiencies and recommend solutions, in preparation for both FDA pre-approval and routine inspections.
» Read case studies ...
» Read case studies ...

Quality Assurance
FDA Current Good Manufacturing Practice Regulations applicable to pharmaceutical and biotechnology establishments mandate a Quality Assurance function. As a product and company move through the process development lifecycle, the requirement for Quality Assurance oversight increases. Working with a PTR Quality Assurance professional fosters a pragmatic approach to regulatory compliance, especially in early stage companies where full-time onsite staff is unnecessary. For later-stage companies, Pharma Technology Resources provides QA professionals to support clients when their staffing levels are not adequate to meet demand for QA input.
» Read case studies ...
» Read case studies ...

Quality Systems Development
As the pre-Clinical development program approaches Phase I Clinical trials, an appropriate Quality System must be designed and implemented. The QA System requires greater sophistication as a product/company moves through Clinical trials and into commercialization. Once commercialization occurs, changing regulatory requirements demand periodic and vigilant review of the QA System. Pharma Technology Resources views implementation of a QA System as an opportunity to systematize good business practices, and tailors the QA System to the specifics of each organization as part of the design process.
» Read case studies ...
» Read case studies ...

SOP Preparation
Standard Operating Procedures support each Quality Assurance System as the documents that describe its implementation. Far more than a writing exercise, SOP preparation requires meticulous attention to details and interpretation of regulatory compliance requirements while providing a realistic and accurate set of instructions. Pharma Technology Resources provides pragmatic and achievable SOPs designed around available client resources. For many SOPs, technical expertise is a critical component. PTR professionals provide a multi-faceted approach to SOP preparation that adds value beyond simply complying with regulations.
»Read case studies ...
»Read case studies ...
»Read case studies ...

Validation Programs
The validation of facilities, equipment, processes, and analytical methods is at the heart of compliance with cGMP regulations. Pharma Technology Resources provides a full range of validation services including: definition of validation programs in the form of validation master plans, protocol development, protocol execution and preparation of validation reports.
» Read case studies ...
» Read case studies ...
» Read case studies ...
» Read case studies ...
» Read case studies ...