Take control of your quality and GxP compliance

Do inspections and audits make you nervous?

Let's fix that! Increase quality and compliance without headaches and busywork. See how revenues increase while reducing overhead. We help you focus on your primary process and get ahead of your competitors. Our unique approach allows you and your team to navigate the regulatory hurdles without breaking a sweat!

Let's fix that! Increase quality and compliance without headaches and busywork. See how revenues increase while reducing overhead.

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for pharma and biotech

How can we help you take control of your quality and compliance?

The basic building blocks

New facility

Building a new factory, lab or warehouse? Getting it GMP certified or GDP certified can be challenging, on-time and within budget. We've built over 50 GMP certified plants.

New facility use cases
GMP certification

popular

Want to distribute (WDA), export or manufacture (MIA) medicines (to the EU)? You need a GMP certificate or GDP certificate first. We'll help you get one, GMP or GDP.

GMP certification use cases
Quality system

Having a pharmaceutical QMS/PQS is a requirement to get gmp certified. Let's start writing or reviewing, we support every type of company and regulatory requirement.

Quality system use cases

More advanced cases

Inspection preparation

Facing a U.S. FDA, EU or WHO regulatory inspection? Let's get you prepared. Including training, mock audits and QMS review, GMP or GDP.

Inspection preparation use cases
Interim QP

Looking for an interim QP? We offer flexible arrangements for experienced Qualified Persons, releasing for the EU market.

Interim QP use cases
Interim RP

The RP keeps the distribution of medicines in check. The RP needs to present on your GDP license. PCS offers interim RP's with flexible hours and contracts.

Interim RP use cases
WHO GMP and prequalification

Looking to sell medicines to the WHO? Then you'll need to get prequalified. PCS helps you get WHO prequalification after dossier submission and acceptance.

WHO PQ use cases
Audits

We audit worldwide; API, excipient, labs, production and distribution. We take care of preparation, execution and reporting.

Audit use cases
Software

The most flexible software for pharmaceutical use on the market. If your process changes, you configure the software to match it. Fully validated and quick deployment.

Software use cases

The "I need you guys to start yesterday!" cases

Inspection/audit response

Need to formulate a comprehensive and decisive response to a regulatory inspection or audit? Formulate your improvement plan with PCS and instill confidence in regulators and clients alike. Show them you're on top of it!

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Media fill failure

If you have a loss of sterility you want it investigated ASAP. Quickly regain control and prevent future occurences taking advantage of our 37 years of sterile experience.

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Loss of control at a CMO

Whenever a CMO starts delivering OOS products you want them in a state of control as soon as possible. But it's a delicate situation. We've been there, many times. PCS helps your CMO return to producing good quality products.

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My new facility is not-compliant

Someone constructed a new facility, they said they knew GMP. But they didn't. Now you can't start and delays are costly. We'll use our extensive knowledge and risk assessments to see what's good and what needs fixing to get you up and running ASAP.

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manage compliance

Fast-track your GxP compliance

PCS helps you organize, plan and manage your compliance projects and issues. Together with your team we ensure swift GxP regulatory compliance that will pass any (regulatory) GxP inspection.

optimize quality

Get the quality your company deserves

With PCS you make quality work for you. Show everyone how a process-centered design inflates revenue and decreases defects. Together we will empower your team to seamlessly and efficiently deliver high quality pharma & biotech products while meeting regulatory GxP requirements.

Every pharma & biotech company needs the right quality and compliance.

What is your challenge?

You're in good company

Join the leading pharmaceutical and biotech brands using PCS' services to optimize their processes or compliance.
See some of our past projects.

How can we help?

Get in touch by sending us a message

Or have a look at our most popular products