Laboratory Services
MEDVACON can significantly bolster your laboratory operations by offering expert consultations in various research fields, and assistance in maintaining regulatory compliance. They can also enhance efficiency by optimizing laboratory processes, providing specialized training for lab staff, and offering effective data management and analysis solutions. Tailored to meet the unique needs of each company, MEDVACON’s services are designed to accelerate drug development, ensure legal and safety standards, and support the overall innovation and competitiveness of pharmaceutical laboratories.
MEDVACON’s Experts Have the Tools Your Company Needs to Laboratory Compliance
From Project Management Training, to Computer System Validation and even staffing, MEDVACON is your go to company for all your Laboratory needs.
MEDVACON Can Assist With The Following Pharmaceutical Laboratory Projects:
- Project Management Training Lab audits/ FDA inspection readiness services
- Facility and utility commissioning and qualification: evaluation of architectural and PID
- GLP and GMP facility design and implementation
- Instrument qualification and method validation
- Computer System Validation (IQ/OQ/PQ)
- Process Validation
- CLIA / CAP Compliance
- Process optimization through 5S and Lean techniques
- Technology Transfers (if moving from one of your current labs)
- Oversight of HVAC, water, air, and electrical systems
- Project Management (particularly during the bid process: to ensure alignment with specs, documentation compliance; collaborate with the GC, subcontractors, etc.)
- GLP / GxP Training
- Staffing/ Talent Acquisition (if hiring for your facility)
Example Projects
Laboratory Equipment Qualification
An API manufacturer enlisted MEDVACON to perform laboratory equipment qualification and system suitability testing for both lab and manufacturing equipment. The goal was to produce system suitability and equipment qualification documentation, affirming the validated state of the lab equipment. The assessment and subsequent tasks were carried out onsite by a MEDVACON Senior Validation Consultant. The equipment evaluated included UV-visible spectrophotometers, ICP spectrometers, Waters HPLCs, Malvern particle sizers, pH meters, refractometers, density meters, and chloridation titrators. Following the successful completion of this project, the client continued to rely on MEDVACON for ongoing support.
EMA Inspection Readiness – Pharmaceutical Contract Testing Laboratory
MEDVACON was engaged by a client that provides contract testing to the pharmaceutical industry to provide EMA Inspection Readiness services. To assist the client in adequately preparing for the audit as well as continuing to support external customers, MEDVACON provided a senior quality expert and operational SME’s to support the multiple ongoing activities. The MEDVACON team’s readiness activities included: supporting external client interactions, supporting ongoing internal activities necessary to maintain GMP status, interim Project Management of ongoing QA, EQ and CSV initiatives; as well as preparatory activities specifically in support of the upcoming EMA audit of the site. The audit outcome was highly successful, and recognized by the Firm’s leadership; and the client continued to engage MEDVACON in additional compliance activities.
Pharmaceutical Empower and Laboratory Equipment Qualification
MEDVACON was engaged by a pharmaceutical manufacturing company to conduct the computer system validation and equipment qualification related the implementation of Waters Empower 3 Chromatography Software system and equipment into the laboratories. MEDVACON developed the validation plan, all protocols, additional documentation around system operation, and executed all the validation documents for the Empower software as well as the hardware Lace boxes. The project resulted in the successful validation of the system and MEDVACON was retained by the client to conduct additional work at the site.