Area Served
Pharmaceutial
MedReg Consultants has an unsurpassed reputation for excellence in technical,
regulatory consulting, and guidance services for the Pharmaceutical Industry,
including generic and new drug products, OTC, and monograph drugs, and many more.
MedReg Consultants is proficient in the development, implementation, and management
of diversified projects involving compliance, scientific principles, technical
aspects, and regulatory requirements related to pharmaceutical products.
Quality Assurance and Control
Quality Assurance and Control
The MedReg team includes a powerful blend of consultants having a industry experience—including leading scientific and technical experts who help ensure that recommendations are not only scientifically and technically accurate, but also actionable.MedReg Consultants are particularly skilled in assessing and enhancing quality assurance and controls—from the way technical issues are handled to the organizational structure of quality units.
Leveraging vast knowledge and experience, MedReg Consultants assists clients in:
↪ Evaluating written procedures and standard operating procedures
↪ Helping to interpret regulations in concert with industry standards
↪ Developing laboratory quality, analytical methods, methods validations, and product component specifications
↪ Creating a program to meet current FDA expectations for GCP Compliance
↪ Consulting self-evaluations
↪ Building sampling plans
↪ Performing trend analysis
↪ Providing corporate oversight programs and enhancement—including good governance practices; corporate quality/compliance functions and oversight practices; and independent advice to CEOs, senior managers, and board members
↪ Implementing site oversight programs, including internal audits and performance metrics
↪ Reviewing and enhancing management controls
↪ 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
Scientific and Technical Assistant
Scientific and Technical Assistant
One of Medreg Consultant's key differentiators is the cadre of scientific and technical experts. With decades of experience in the industry, the consultants have the real-world knowledge and experience required to deliver accurate, actionable recommendations.Members of the Science and Technology Practice work seamlessly with our other practice groups to deliver results for clients facing difficult compliance and regulatory problems.
Scientific Assistance:
↪ Develop and enhance laboratory controls
↪ Perform laboratory investigations
↪ Assess bioequivalence studies and evaluate adequacy of bioanalytical methods and laboratories
↪ Optimize product formulation and processes
↪ Assess product stability
Technical Capabilities:
↪ Evaluate process designs
↪ Develop or refine process control strategies
↪ Assess and improve process analytical technology (PAT)
↪ Evaluate the development of analytical methods
Compliance
Compliance
Our team of highly experienced experts from industry provides a full range of mission-critical services to the regulated industry. We work with clients to design and implement effective and efficient business processes, assuring sustainable compliance through optimal integration of scientific, technical, and regulatory principles.By monitoring and tracking the ever-changing regulatory and technical environment, as well as regularly evolving industry practices, MedReg Consultants helps clients stay current and compliant.
Strategic Planning
Strategic Planning
MedReg lineup of Strategic Planning services features global product development strategy, clinical, non-clinical, CMC, and regulatory gap analysis, product and indication prioritization, regulatory pathway optimization and acceleration strategy, global labeling, marketing authorization applications, submission planning, and patient-focused development.
Facilities Design and Evaluation
Facilities Design and Evaluation
MedReg Consultants is skilled in assisting organizations as they encounter facilities design, construction, or adaptation—or as they encounter facilities-related compliance problems.Through a powerful blend of compliance, regulatory, scientific, and technical expertise, MedReg is highly effective in:
↪ Analysing, developing, and/or enhancing engineering requirements, specifications, and drawings, including HVAC, water, sterilization, and dust-control systems
↪ Developing environmental and processing-room requirements
↪ Recommending effective flow of materials, equipment, and personnel
↪ Assessing and enhancing facilities requirements vis-à-vis manufacturing, assembly, packaging/labelling, and distribution operations
↪ Addressing the facilities requirements of laboratory operations
↪ Performing factory acceptance testing of equipment (FAT)
↪ Conducting audits during construction and installation phases
↪ Qualifying facilities for sterile, low-bioburden, and non-sterile products
↪ Qualifying facilities for intermediates, APIs, and finished drug products
↪ Qualifying facilities for medical device components and finished products
System Process Validation or Qualification
System Process Validation or Qualification
MedReg Consultants is available to help evaluate the adequacy of products, equipment, and facility. MedReg consultants provide expert, unbiased assessments that help ensure that strengths are recognized, and weaknesses are addressed.MedReg delivers both strategic recommendations and tactical, front-line support through services, including programmatic assistance, validation/qualification activities, Process Validation, Cleaning Validation and computer systems validation.
Remote services from MedReg
Remote services from MedReg
Current Remote Service Offerings Include:↪ Application (ANDA, NDA, 510K, DMF, NHP etc.) review and assembly
↪ Policy, Standard, SOP writing
↪ Due Diligence Assessments
↪ CAPA plan reviews
↪ Quality Systems Implementation and Remediation
↪ Investigation reviews and writing
↪ Batch record reviews for product disposition
↪ Audits (Internal and Supplier) done virtually through technology
↪ Facility Design Reviews
↪ Data Integrity Reviews - Lab and Manufacturing
↪ Cross-contamination assessments
↪ Environmental monitoring assessments
↪ Training
↪ Annual GMP Training and certification
↪ Supplier Quality Management
↪ Quality Agreements
↪ Analytical Method Review
↪ Strategies for conducting manufacturing activities with only essential personnel