Services:

Compliance

Highly experienced experts from the FDA regulated industry provide a full range of mission-critical services to the regulated industry. We work with clients to design and implement effective and efficient business processes (simplifying process), assuring sustainable compliance through optimal integration of scientific, technical, and regulatory principles.

SbyS group helps clients to stay current and compliant by monitoring and tracking the ever-changing regulatory technical environment, as well as regularly evolving industry practices.  This will help your organization’s journey toward a sustainable, compliant, and successful company-wide data governance and integrity program.  Data integrity expectations are being looked at more broadly by regulatory agencies about managing vulnerabilities and risk across a company’s operations and for all GxP data.

Portfolio of capabilities:

Document Preparation/Reviewing and preparing key documents for review by FDA, including: NDAs, INDs, ANDAs, NADAs, DMFs.  In addition to extensive experience in:

·         Developing effective systems to comply with the requirements for adverse drug event (ADE) management and reporting.

·         Reviewing product labeling, advertising, and promotional materials for regulatory compliance.

·         Providing technical writing for protocols, reports, specifications, policies, and procedures.

Compliance Problem Resolution

Resolving compliance problems is SbyS group expertise. With the experience will help organizations that are facing difficult challenges and have earned a solid reputation for delivering high-quality insight and recommendations to overcome those challenges.

·         Responding to an FDA 483 inspection.

·         Responding to an FDA Warning Letter.

·         Meeting with the FDA to resolve disputes.

·         Implementing corrective and preventive action (CAPA) programs-including development, execution, monitoring, and project management.

Training

SbyS group prepares and delivers custom and specific to meet the clients’ requirements for training programs on the following topics related to the FDA:

·         Regulatory affairs.

·         International regulations.

·         FDA guidance.

·         Regulatory agencies policies and policy updates.

·         Current FDA trends and industry/FDA actions.

·         Risk management.

·         GMP, GCP, GLP.

·         Quality Control Laboratory’s operations.

Audits and Reviews

Assess organizations’ compliance with:

·         GMP (good manufacturing practice) for intermediates, active pharmaceutical ingredients (APIs), and finished drug products.

·         QSR (medical device “GMP”)

·         GLP (good laboratory practice)

·         DEA (Drug Enforcement Agency)

Extensive experience in:

·         Performing “mock” FDA pre-approval inspections (Site Facilities, PAI and GMP inspections)-helping to ensure that problem areas are identified and addressed before the real inspection.

·         Developing drug diversion prevention and counterfeit investigation programs.

·         Auditing adverse drug event (ADE) programs-from collection and evaluation through reporting and follow-up.

·         Qualifying vendors.

·         Performing due diligence.

·         Conducting regulatory audits.

·         Auditing documentation, including application integrity audits.

Investigations

Extensive experience performing investigations within the regulated industry all life-sciences sectors including small-molecule, large-molecule/biopharma, and medical devices, and in all business areas from third-party suppliers to manufacturing and laboratory and quality assurance, to distribution, post-market, and corporate systems.

Continuous Improvement

Reviewing and enhancing organizational structures—including functions, reporting relationships, responsibilities, staffing and competence; communication systems and performance (vertical and horizontal); and independence, staffing, and competence of quality units.