Our story

+25 years of pharmaceutical excellence in the Benelux

Founded in 1998 by industrial pharmacist Erika Rottey, M.P.C.A. International BV has grown from a one-person consultant into a trusted team of 20+ pharmaceutical professionals, all dedicated to quality, integrity and flexibility.

1998
Founded in Ghent, Belgium
25+
Years of pharmaceutical expertise in the Benelux
20+
Qualified pharmaceutical professionals
Erika Rottey, oprichtster MPCA International Erika Rottey, Founder
1998
Founded in Ghent
Our founder

Erika Rottey,
Industrial Pharmacist

M.P.C.A. International BV was founded in January 1998 by Erika Rottey, an industrial pharmacist with extensive experience in Regulatory Affairs, RIP, GMP/GDP and Pharmacovigilance since 1991.

Starting with national registration procedures for the BENELUX and expanding into European procedures, Erika quickly developed a deep understanding of the pharmaceutical industry's needs. Her experience in international drug development became the foundation of a company built on responsiveness, knowledge and genuine dedication to clients.

Erika holds all accreditations to perform pharmaceutical services as a Qualified and Responsible Person: QP n° 1319, RP, RIP n° 656, EU QPPV for CIOMS reporting & XEVMPD and LCP.

"Never give up until the job is done and make the difference for all customers."
— Erika Rottey, Founder & Managing Director
Our journey

From startup to
Benelux reference partner

1990

Graduating as an industrial pharmacist

Erika Rottey graduates as an industrial pharmacist, laying the foundation for a career built on deep regulatory and quality expertise.

1991

FAMHP accreditation as Qualified Person

Erika receives her accreditation from the Belgian Federal Agency for Medicines and Health Products (FAMHP): QP n° 1319.

January 1998

MPCA BV is founded

Born as a project management and regulatory affairs consultant, developing a wide range of flexible pharmaceutical services for the Benelux market.

1998 to 2009

Accreditations & early growth

Erika develops her further accreditations: RP, RIP n° 656, EU QPPV and LCP. First employee hired in 2004 following increasing client demand.

2009 to 2018

Building a specialist team

Many qualified pharmaceutical consultants join the company as the service portfolio and client base continues to grow.

2018

20th anniversary

MPCA BV celebrates 20 years of trusted pharmaceutical consultancy in the Benelux.

2019

International expansion

MPCA bv expands internationally and officially renames to M.P.C.A. International BV, reflecting a growing portfolio of European and international projects.

2020

New headquarters in Ghent

The team grows to 13 skilled pharmaceutical specialists and moves to new offices in Ghent (Poortakkerstraat 93, Sint-Denijs-Westrem).

January 2023 🎉

25th anniversary

M.P.C.A. International celebrates 25 years of pharmaceutical excellence, and continues to grow as the trusted regulatory partner for pharmaceutical companies in the Benelux and beyond.

Present

A trusted team of 20+ professionals

Today, the team holds around 20 professionals and offers extensive knowledge and expertise to support our clients in the pharma and healthcare industry.

What drives us

Mission & Vision

Mission

Supporting the full product lifecycle

Our pharmaceutical services and expertise are available throughout the entire product lifecycle of medicines and healthcare products, from initial regulatory strategy to long-term lifecycle management in the Benelux and beyond.

Vision

Your reference service partner

M.P.C.A. International aspires to be your reference service partner, bringing and keeping your medicines and healthcare products in the market through deep Benelux regulatory expertise and genuine dedication to your success.

How we work

Our core values

Everything we do is guided by three well-defined core values, shaping every interaction, every service and every deliverable.

01

Quality

We operate with our own stand-alone QMS, a Quality Management System designed to the highest pharmaceutical standards. Standardised processes, continuous training and rigorous compliance are at the heart of every service we deliver.

02

Integrity

We work with full transparency and professional integrity at all times. Acting in the best interest of our clients, their products and the patients who depend on safe and compliant medicines and healthcare products.

03

Flexibility

No two pharmaceutical companies are the same. We adapt our services to the exact needs of each client. From in-house placements and long-term retainers to our MPCA-online on-demand advice service.

"M.P.C.A. International aspires to be your reference service partner. Bringing and keeping your medicines and healthcare products in the market."

Mission & Vision — M.P.C.A. International BV, Ghent
Our team

20+ qualified specialists,
ready to support you

Our colleagues are highly qualified and continuously trained to stay up-to-date with the most recent EU regulations, guidelines and best practices in pharmaceutical consultancy.

M.P.C.A. International currently works with a team of 20+ pharmaceutical professionals, combining permanent staff with a network of expert freelance consultants. Together, we cover the full spectrum of pharmaceutical consultancy services for the Benelux market.

Join our team

Our team includes, among others

(Industrial) Pharmacists
Medical doctor
Biomedical scientist
Bio-engineer
Laboratory specialist
IT specialists
Business Development Manager
Marketing specialists
Frequently asked questions

About M.P.C.A. International

What is M.P.C.A. International?
M.P.C.A. International is a pharmaceutical consultancy based in Ghent, Belgium, founded in 1998. It delivers expert Regulatory Affairs, Pharmacovigilance, Quality (QP/GMP, RP/GDP), RIP and Pricing & Reimbursement services across the Benelux and beyond.
Where is M.P.C.A. International located?
M.P.C.A. International is headquartered in Ghent, Belgium (Poortakkerstraat 93, 9051 Sint-Denijs-Westrem) and serves the Belgian, Dutch and Luxembourg markets as well as European procedures.
When was M.P.C.A. International founded?
M.P.C.A. International was founded in January 1998 by industrial pharmacist Erika Rottey and has more than 25 years of experience in pharmaceutical consultancy.
What services does M.P.C.A. International offer?
We offer Regulatory Affairs, Pharmacovigilance (including EU QPPV and LCP), Qualified Person and GMP services, Responsible Person and GDP services, RIP (Responsible for Information and Publicity) and Pricing & Reimbursement. We also offer specialised applications such as eCTD submissions, readability user testing, GxP auditing, training, private label and MA scouting.
Which types of products does M.P.C.A. International work with?
We work across five categories of regulated healthcare products: medicines (human and veterinary), medical devices, food supplements, cosmetics and biocides.
How can I contact M.P.C.A. International?
You can reach M.P.C.A. International by phone on +32 9 312 30 09, by email at info@mpca.be or via the contact page.
Work with us

Ready to work with our
team of specialists?

Schedule a no-obligation consultation. We'll assess your regulatory needs and propose a tailored approach, at no cost.