Regulatory consulting services customized for your specific project needs

Pro Compliance Experts has the skills and wealth of experience to understand and develop people and organizations. We do consulting work with our clients to optimize their performance and learning curve and help them to achieve their goals. We make this possible through sharing best practices and providing mentoring, training and support. We will be the catalyst that will help you grow and make the changes you want to make. We offer a unique approach to your requirement, are approachable and provide tailor made advice in an engaging and motivating manner.
Pro Compliance Experts offers a wide range of Pharma, Bio-technology, Medical device, Healthcare & HR industries Consulting programs, designed to help your business develop and your staff enhance their skills. These programs are designed to focus on your specific needs, provide the appropriate solutions for your business and improve your core competencies.
The Consulting arms of Pro Compliance Experts rely strongly on their strategic capabilities and relevant industry expertise.

Compliance Consulting

Current Good Manufacturing Practice (cGMP) regulations require all manufacturing processes to be clearly defined and controlled. Any changes that have an impact on the quality of the drug are evaluated and validated as necessary. All critical processes are validated to ensure consistency and compliance with specifications. Pharmaceutical companies are keenly aware that they must ensure ongoing compliance with the regulations and be in a state of "inspection-ready" in the event of an inspection from a regulatory body.

Quality Systems

Manufacturers must establish and follow quality systems to ensure that their products consistently meet applicable requirements and specifications. Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle.

Pro Compliance Experts offers the following but is not limited to:
  • Site Master Plans
  • Periodic Reviews
  • Change Control
  • Procedures
  • Policies and Guidelines
  • CAPA
  • Calibration and PM Procedures
  • GAP Analysis / Risk Assessments
  • GMP Training

Compliance Audits

Pro Compliance Experts designs audit and corrective action plans to accommodate our clients´ needs, including MHRA, EMEA, ANVISA, Canadian Health, TGA and FDA regulations.

We offer the following but not limited to:
  • Internal Audits
  • Preapproval Inspections
  • Contract Manufacturing GMP Audits
  • API Manufacturer Audits
  • Software Vendor Audits
  • IT Systems Audits
During our audit process, we evaluate your existing quality systems, and provide an exact assessment on the company's various systems. We then recommend a plan of corrective action, which allows the company to achieve the quality assurance required by the respective regulatory agencies.

A pharmaceutical auditing plan may include corrective actions on:
  • Documentation and Record Control
  • Change Control
  • Manufacturing Process and Equipment
  • Training
  • Validation and Qualification
The elements and steps involved in the audit process may differ depending on the type of audit required and its applied regulatory standards. Pro Compliance Experts works with its clients and takes an active role to ensure corrective actions are implemented to remediate the gaps identified during the audit. The goal of having a Quality System is the consistent production of safe and effective products and ensuring that these activities are sustained. A robust quality system will promote process consistency by integrating effective knowledge-building mechanisms into daily operational decisions.
Pharmaceutical auditing expertise includes writing and review of validation policies, guidelines, site master validation plan and SOP from design qualification to performance qualification steps.

GMP Training

Pro Compliance Experts provides cGMP training programs to fit your needs, starting from cGMP orientation for new hires to annual cGMP training on various cGMP modules. Our new hire cGMP orientation is an overview of basic GMP concepts and emphasizes, to new employees, the importance of understanding and following governing regulations. This will give them a good background to promote regulatory compliance when they receive On-the- Job Training (OJT).

Validation Consulting

Pro Compliance Experts Consultants possess extensive knowledge in various pharmaceutical manufacturing processes, computerized automated control systems, computer systems, laboratory instrumentation & information systems, and manufacturing equipment, packaging equipment, gap assessments and remediation programs. Our services include but not limited to:

Equipment Qualification
We provide the technical expertise to conform to all user requirements, design specifications, and regulatory requirements in the fields of Manufacturing Equipment, Packaging Equipment and Analytical Laboratory Equipment. Process Validation Processes could encompass manufacturing, filling, sterilization, and packaging within the FDA regulated Pharmaceutical, biopharmaceutical, API and Medical Device industries. Manufacturing Process Validation Services involve a comprehensive and in depth exploration and evaluation of every aspect of the manufacturing environment, including Aseptic Processing Validation, Environmental Baselines, Liquids (sterile/non-sterile), Ointments, Product Validation, Suspensions, Capsules and Tablets.

Process Validation
Processes could encompass manufacturing, filling, sterilization, and packaging within the FDA regulated Pharmaceutical, biopharmaceutical, API and Medical Device industries. Manufacturing Process Validation Services involve a comprehensive and in depth exploration and evaluation of every aspect of the manufacturing environment, including Aseptic Processing Validation, Environmental Baselines, Liquids (sterile/non-sterile), Ointments, Product Validation, Suspensions, Capsules and Tablets.

Computer System Validation
Computer System Validation (CSV) means establishing documented evidence that provides a high degree of assurance that a specific computerized system will consistently operate in accordance with pre-determined specifications. Computer-related system requirements document is the foundation for the computerized system validation. A successful validation project depends upon proper definition of the system.

We can create the following documents and execute the validation protocols for your system.
  • User Requirements Specification (URS)
  • Validation Change Control
  • Project Validation Plan
  • Functional Specification (FS)
  • Design Specification (DS)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Functional Requirement Assessment (FRA)
  • Failure Modes Effects Analysis (FMEA)
  • Data Migration (if any)
  • Reports
Cleaning Validation
The prevention of cross contamination is an essential component of any GMP program and is necessary to ensure the safety of drugs, biologics and medical devices used in human or veterinary applications. We determine the cleaning processes for each piece of equipment.

Analytical Method Validation
Analytical Method Validation is defined as the process of proving (through scientific studies) that an Analytical Method is acceptable for its intended use. Analytical Methods Development and Validation play important roles in the discovery, development and manufacturing of pharmaceuticals. The official test methods that result from these processes are used by QC lab to ensure the identity, purity, potency and performance of drug products.

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