Contract Research Organizations (CROs)
WHO WE ARE
We are Leaders in Biomanufacturing Strategy & Execution. We Foster Partnerships.
Excel Pharma Tech, a Precision for Medicine Company, is a consulting firm providing biomanufacturing strategy and execution. Our services include turnkey capital projects, tech transfers and facility builds; owner’s representation; program/project management; validation; quality, regulatory and compliance; engineering and automation; serialization track and trace; reliability, maintenance and asset management and more. We partner with startups, established life science corporations, advanced therapy organizations, universities, hospitals, government agencies, financial institutions, not-for-profits and CROs/CMOs.
Services
Quality, Compliance and Regulatory Program Development
We offer a range of quality, compliance and regulatory services:
- Quality Assurance Lead Backfill
- Vendor Auditing (CMOs, Equipment Supplier Computer, IT)
- Compliance Remediation
- CMO Management, Quality Agreements, Person In Plant
- CMO Capacity and Feasibility Analysis
- Quality Risk Assessment
- NC & CAPA Ownership
- Investigation & Root Cause Analysis Program Implementation
- Regulatory Strategy & Submissions
- Regulatory Inspection Preparation & Readiness
- Audit Preparation & Support
Validation Services
Our experienced validation team will document the consistency, quality, and accuracy of your systems, methods, and processes. We understand the different validation requirements for GMP, GLP, and GCP systems and the best ways to ensure compliance with FDA, EMA, and other global regulations.
- Traditional Commissioning and Qualification
- Validation Program Development
- Process Validation
- Computer Validation
- Cleaning Validation
- Steaming Validation
- Laboratory Validation
Our Services
Comprehensive biomanufacturing solutions for precision medicine and life sciences.
WHAT CLIENTS SAY ABOUT US
Pharma Excel Tech has been instrumental in guiding us through complex regulatory challenges and ensuring compliance with stringent industry standards. Their team's expertise and dedication have consistently exceeded our expectations. We highly recommend Pharma Excel Tech to any company seeking top-notch regulatory and compliance services.
Working with Pharma Excel Tech has been a game-changer for our biotech startup. Their validation services were crucial in establishing the credibility of our processes, and their strategic consulting helped us navigate the regulatory landscape with confidence. Pharma Excel Tech's team is not just knowledgeable; they are also incredibly supportive and responsive. We're grateful for their partnership.
Pharma Excel Tech has been an invaluable partner in ensuring the quality and compliance of our manufacturing operations. From conducting thorough vendor audits to implementing robust quality assurance programs, they have helped us elevate our standards and exceed regulatory requirements. Their professionalism, attention to detail, and commitment to excellence make them our go-to partner for regulatory and compliance services.
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Industries Served
Biotechnology Industry
Medical Device Manufacturing Industry
Clinical Research Organizations (CROs)
Pharmaceutical Industry
Contract Manufacturing Organizations (CMOs)
FAQ's
Pharma Excel Tech offers a comprehensive range of services including quality assurance, compliance, regulatory affairs, validation, and strategic consulting tailored to the pharmaceutical and life sciences industries.
Pharma Excel Tech distinguishes itself through its deep industry knowledge, experienced team of consultants, and commitment to delivering customized solutions that exceed client expectations.
Pharma Excel Tech offers services such as quality assurance, compliance remediation, regulatory strategy and submissions, validation services (including process validation and cleaning validation), and strategic consulting for business and manufacturing.
Yes, Pharma Excel Tech works closely with clients to understand their unique requirements and tailors its services accordingly to ensure the best possible outcomes.
Pharma Excel Tech maintains rigorous quality control processes, employs experienced professionals, and adheres to industry best practices and regulatory standards to consistently deliver high-quality services.
The engagement process typically involves an initial consultation to assess client needs, followed by proposal development, project initiation, ongoing communication, and regular progress updates.
Pharma Excel Tech utilizes various communication channels including email, phone calls, video conferences, and project management tools to ensure transparent and efficient communication with clients.
Pharma Excel Tech meticulously plans and schedules project activities, closely monitors progress, and proactively addresses any issues or delays to ensure adherence to agreed-upon timelines.