PerfMaster Consulting

About PerfMaster

33+ years of experience. Agile, risk-based. Ready to support your goals.

Our belief

Without the right human resources that are developed, engaged, and empowered to deliver performance transformation, there is limited value and impact in the mid to long term. It is at the core of all sustainable successes.

We are a team of experts with 33+ years of experience in Biotech and Pharma. Our expertise spans QMS, manufacturing, regulatory compliance and technology transfer—supporting companies globally with an agile, risk-based approach.

Dubai, UAE · Founded 2023 · Available for missions in EU, US, GCC and internationally.

Learn more about us Follow us on LinkedIn

Our Services

Senior-led consulting to optimize operations and ensure regulatory compliance. We diagnose, plan, mobilise and train to drive results.

Customized training

Training is a strategic lever. High-impact programs on QMS, CCS, validation, Data Integrity & ALCOA+, EMA/FDA/Chinese requirements. Approach: Assessment → Tailored content → Delivery → Training materials. On-site workshops, virtual sessions, or kits for internal reuse.

Inspection readiness

Prepare for regulatory inspections with robust processes, documentation, and training so you're audit-ready. We help you navigate pre-approval, routine, and for-cause inspections from FDA, EMA, NMPA, and other health authorities.

Regulatory strategy & compliance

Gap assessments, regulatory strategy (China, FDA, EMA), remediation across sites. China compliance: Regulatory framework → GMP comparative → Gap assessments → Remediation.

Scale production

From clinical to commercial scale: we help you design, validate, and ramp up manufacturing efficiently.

Quality Management System

Strengthen your QMS, improve right-first-time quality, and ensure sustained regulatory compliance.

Market launch

Launch into new markets with clarity on supply, compliance, and commercial operations.

Our Expertise

We offer consulting to help pharmaceutical companies optimize operations and ensure regulatory compliance across markets.

With deep expertise in Quality Management Systems, we ensure that our clients' products meet global regulatory standards.

Quality Risk Management (QRM) aligned with ICH Q9 guidelines
Sterility Assurance Program Development
Third-party Vendor Qualification & Oversight
Continuous Improvement using Lean Six Sigma methodologies
Inspection & Audit Readiness for FDA, EMA, and other global agencies
Post-market Surveillance & Compliance

We specialize in supporting manufacturing teams to achieve excellence in both commercial and development environments.

Process and Analytical Method Transfers
Manufacturing Plan Implementation
Gap Analysis and Risk Mitigation Support
Continuous Process Verification (CPV) and Process Performance Qualification (PPQ)
Compliance with GMP and CMC regulations for solid and injectable dosage forms

PerfMaster Consulting offers expertise in navigating complex regulatory environments, ensuring alignment with global standards across US, EU, China, Brazil, and Russia.

Regulatory Submission Preparation (NDA, BLA)
Global Compliance Alignment for Multinational Products
Inspection Support and Preparation
Change Control Management

We partner with our clients to not only meet compliance standards but to drive operational excellence that fosters long-term growth and success.

Our Solutions

We deliver solutions shaped by your goals, operational reality, and regulatory requirements.

End-to-End Regulatory Compliance Solutions Full-spectrum regulatory strategy and submission management; gap assessments and remediation plans; compliance audits and inspection readiness for FDA, EMA, and other global authorities; post-market surveillance support.
Manufacturing Optimization & Process Excellence Lean Manufacturing and Operational Excellence; Technology Transfer Management (process and analytical methods); CPV and PPQ; capacity expansion strategies.
Agile Quality Management Systems (QMS) Tailored QMS frameworks aligned with global standards (FDA, EMA, ICH); digital QMS solutions; training in QRM and root cause analysis; sterility assurance programs.
Strategic Risk Management & Compliance Consulting Customized risk assessment and mitigation planning; risk-based quality strategies (ICH Q9); regulatory intelligence systems.
Flexible Project Management & Advisory Services Critical initiatives (product launches, regulatory submissions, inspections); interim leadership and cross-functional project management; expert advisory on quality transformation, scale-up, and regulatory alignment.

From first product launch to global scale-up, we adapt to your lifecycle. We support your growth with performance, compliance, and innovation.

Success Stories — Past experiences and results we have delivered.

Training Topics

Our customized training covers technical and regulatory topics such as:

Quality Management Systems (QMS)
Contamination Control Strategy (CCS)
Biological Drug Substance Manufacturing
Equipment Qualification & Process Validation
Cleaning Validation
Environmental Monitoring, Gowning, Cleaning & Disinfection
EMA, FDA & Chinese regulatory requirements
Data Integrity & ALCOA+

China Compliance Approach

When navigating Chinese regulatory requirements, we apply a clear, repeatable methodology.

Regulatory framework Identify applicable regulatory requirements.
GMP comparative Develop compliance strategy and methodology.
Gap assessments Perform assessments and deliver reports.
Remediation Define and support mitigation actions.

Discuss your project

Get in touch

Sectors of Excellence

Specialized solutions for pharmaceutical and biotech. We understand your challenges and stay current on regulations.

Pharmaceuticals

API and drug product development, manufacturing, quality, and supply chain.

Biotechnology

Biologics, cell & gene therapy, and advanced therapies across the lifecycle.

2023 Founded

Dubai HQ

Pharma & Biopharma Focus

Contact

Let's talk about your goals, and how we can help you master them.

📍 Dubai, UAE · Available for missions in EU, US, GCC and internationally

Email contact@perfmasterconsulting.com Telephone +971 52 326 7077 LinkedIn PerfMaster Consulting