Regulatory Compliance

S&D International Group Inc.

For life science companies, regulatory compliance is risky business. Unless you can mitigate compliance risk, remediate potential violations and stay ahead of the changing regulatory landscape, your reputation and your bottom line could be threatened.

S&D Group not only understands the issues and the mechanics of managing the sample lifecycle, but also has the experience and the ability to act as your single-source provider of comprehensive, integrated solutions for regulatory compliance management. S&D Compliance Solutions offers you the resources and specialized guidance you need to cost-effectively comply with the policies and regulatory requirements of the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and applicable state regulatory requirements and registration processes.

State Services		Computer Systems Validation Services
Don't let state legislatures throw you into a state of confusion. With S&D State Services helping you monitor and respond to the latest state regulatory changes, you'll minimize risk, keep compliance costs in check and simplify the management of internal processes.		Compliance doesn't stop with people and processes. Our Computer Systems Validation Services help you quickly and cost-effectively meet all applicable requirements for your regulated computer systems.

Regulatory Compliance Consulting

Sample Management Solutions

We've got you covered,
S&D International Group Federal Regulatory Compliance Consulting will help you stay ahead of operational and regulatory requirements by the DEA and FDA. We'll also help you deploy valuable risk-mitigation programs like compliance training.

Problems of Self regulation

In general, the regulatory agencies, through laws and guidelines provide a broad overview of what they want pharmaceutical companies to provide, but not how to do it. They will audit the system and list any areas where they feel the approach is not satisfactory, but generally do not provide help on how to fix the situation. This often leads to companies performing more work than is necessary ‘just in case’.

Changing Terminology

Given the wide range of the pharmaceutical industry from Research and development to Production, Delivery and Sales and the different regulations like GMP and GLP enacted in different ways in different countries the basic terminology used can be different. This may be solved one day by the International Conferences on Harmonisation (ICH) but until then will be a major problem.

Conquer the compliance issues associated with sample management. S&D Group offers the industry's only end-to-end, single-source sample management solution capable of enhancing your sampling effectiveness and reducing your compliance risk.

Problems in Testing

Testing, metrology, and documentaion requirements for validation are challenging. For even relatively simple computer programs, it quickly becomes impossible to test every permutation and route through the program. This was described by Boehm (1970).

Validation Specialty Firms

Regulatory, development, quality system, manufacturing, packaging, and software validation are often partially or fully outsourced to niche specialty firms who can keep up with the field.

The goal for the regulators is to ensure that quality is built into the system at every step, and not just tested for at the end, as such validation activities will commonly include training on production material and operating procedures, training of people involved and monitoring of the system whilst in production. In general, an entire process is validated; a particular object within that process is verified. The regulations also set out an expectation that the different parts of the production process are well defined and controlled, such that the results of that production will not substantially change over time. This also extends to include the development and implementation as well as the use and maintenance of computer systems. The software validation guideline states: “The software development process should be sufficiently well planned, controlled, and documented to detect and correct unexpected results from software changes.”