Our services


Regulatory affairs

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Responsible Person for Information and Publicity

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Qualified Person for Good Manufacturing practices

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Responsible Person for Good Distribution Practices

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Pharmaco vigilance

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Pricing and Reimbursement

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Regulatory Affairs

  • Are you planning for meetings with regulatory authorities?
  • Is your drug eligible for Orphan Drug status?
  • Would you like to benefit from our experience in managing electronic submissions?
  • Are you an SME and would you like to benefit from the financial and administrative help provided by the European governments?
  • Would you like to analyse your chances to meet the requirements for market access in BENELUX, as well as its impact on other EU markets

From initial strategy development up to market introduction, M.P.C.A. International BV provides the services you need with the quality you require.

Regulatory Affairs
European Drug Regulatory Affairs Consulting & Applications.
At M.P.C.A. International BV, we offer our clients unique and tailor-made support with European regulatory requirements. We provide expert guidance and know-how to optimise the time to market for your products. Whether as a stand-alone service or as part of the product development program, M.P.C.A. International BV delivers expert European regulatory services tailored to meet your exact requirements.

How we do it:
Our regulatory affairs services can be divided into three main areas, as follows:

1. Contract regulatory affairs
We can offer a broad range of services using our staff, based in our offices in Ghent. Hereafter is a series of tasks we generally offer our clients:

    2. In-house placements
    We recognise that many clients prefer to have contract regulatory staff working in their own offices, as this allows easier access to documentation and greater interaction with the project team. We therefore provide this service and currently have several contracts where we place our staff for several days a week/month or for a fixed period full-time.

    3. Immediate access to regulatory advice
    We have found that some of our clients need ad hoc advice regularly. To meet this demand, we have launched a service called 'MPCA-on-line'. By sending us your questions by e-mail, we send you in return instant access to advice. You merely pay for the time it takes us to respond to your questions.

    Responsible Person for Information and Publicity

    Providing objective, accurate and complete information on medicinal products is the utmost important goal of the pharmaceutical industry. We can assist you with achieving this in a legally acceptable pharmaceutical manner.

    Offering bonuses and benefits, advertising, organising science congresses, handing out free samples are all activities subject to strict regulations. We master all the relevant RIP knowledge to provide guidance and assistance to your daily pharmaceutical business. Our staff is fully trained, and we master RIP and Deputy RIP accreditations issued by the EU-BE Health Agency.

    Legal context:

    • The Directive 2001/83/EC of the European Parliament and of the Council of 6/11/2001 on the Community Code relating to Medicinal Products for Human Use (O.J.L-311 28/11/2004) article 98, 1°.
    • The Belgian Law on the medicinal products of 25.03.1964 (B.O.J. 17.04.1964) - revised dd. 01.05.2006 (B.O.J.16.05.2006)article 6ter,9.
    • The Belgian Royal Decree related to the information and advertising for human use medicinal products of the 07/04/1995 (B.O.J. 12.05.1995) – revised dd. 22.11.2006 (B.O.J.08.01.2007) article 13,14 and 15.

    Within our accreditations, we assist pharmaceutical companies in their legal pharmaceutical needs:

    • Verification of the compliance of SPC, leaflets, approval of abbreviated patient information leaflets and their translations and signing the “Declaration of Conformity” for registration and variations on a marketing authorisation by the accredited RIP connected by TQA to your company and reported to the Belgian Agency FAMHP;
    • Assessing and approving promotional materials and establishing an appropriate internal procedure for approving advertising and various promotional activities;
    • Validation and final approval on advertising projects;
    • Overseeing the training of medicinal representatives and the visual aids to generalists, specialist, pharmacist and other healthcare professionals;
    • Ensuring compliances of regulations on distributing free samples (Royal Decree fixing the conditions in which the delivery of medicines for human use in the form of samples can be made of the 11.01.1993);
    • Responsible for the scientific information provided by your company (ex.: questions from patients, professionals, …);
    • Ensuring compliance of regulations on «premiums or advantages» and assessing and approving sponsoring (Royal Decree of 7.04.1995, article 2 §2, article 13 §4, article 15 and law 25.04.1964 on medicines, article 10);
    • Drawing up contracts and agreements with healthcare professionals;
    • And many more services in the same area of medical information and publicity:
      • Marketing material:
        • Full medical and pharmaceutical training courses designed for medical representatives in global or specialised to the represented medicinal drugs (see Training facilities section).
      • Presentations:
        • We listen to your needs, work out a plan and help you prepare presentations that will not be forgotten or ignored easily. We have substantial experience in giving lecture presentations to scientifically and medically qualified audiences in English, French, German, and Dutch.
        • We prepare your presentations and trainings in a variety of areas such as medical, scientific, pharmaceutical, trend, specialised drug information, marketing, etc.
        • We prepare text hand-outs and presentations in electronic form (e.g. MS-PowerPoint®) whichever is most appropriate to your needs.

    Qualified Person for Good Manufacturing Practices

    We demonstrate our commitment to quality by consistently requiring strict QA oversight, through our Qualified Person (QP) services.

    Qualified Person for Good Manufacturing Practices:
    Our experienced QPs:

    • Will help you meet the unique and complex regulatory demands of the EU and UK;
    • Will help to streamline your product in its journey from clinical trial to market release in the EU and UK, giving you the confidence that your investigational or commercial drug product has been processed and released in compliance with local Good Manufacturing Practice (GMP) regulations;
    • Take responsibility for the batch certification and release of Investigational Medicinal Product (IMP) for use in clinical trials and of medicinal products for commercial distribution;
    • Are able to accept personal and legal responsibility, as defined by European and UK legislation, that the medicinal products entering the EU and UK market under their review, have been processed following the principles of GMP as well as manufactured in accordance to their Marketing Authorisation.

    We act as QP for MIA holders under TQA and with a dedicated job description and well-trained to the specific requirements set out in the QMS and support both EU and UK drug product release and batch certification.

    Quality Assurance for Good Manufacturing Practices:

    • We act as the Quality Assurance Department on behalf of several licence holders, ensuring they meet their requirements for document control and quality review.
    • Cloud-based or paper-based Standard Operating Procedures (SOPs) can be adapted to local requirements, ensuring the current copy of any SOP is available at the point of use.
    • All our SOPs are dedicated to each client; we do not sell any ‘off the shelf’ systems. We ensure best practice is applied to each Quality Management System (QMS).
    • We recommend regular Quality Review Meetings with Key Performance Indicators to ensure full oversight of the QMS by all relevant parties – the licence holder, service providers, quality department, etc.
    • We run a risk-based SOP audit program to ensure that every SOP is periodically reviewed for compliance and that the SOP is being used as intended.
    • We have established and proven systems for Corrective Action and Preventative Action (CAPA) system and Change Control that can be adapted for any situation.
    • We have a range of training methods, considering new starters, minor amendments, major revisions and periodic review.
    • We can provide a system to meet your specific quality requirements – GMP, GDP, Medical Device (ISO13485), Cosmetic – to ensure compliance with current regulations.
    • We develop Quality Management Systems to be applied in MIA authorised environment
      • Cloud- or Paper- Based Solutions
      • Standard Operating Procedures
      • GMP, GDP, Cosmetic, Medical Device ISO13485
      • CAPA, Audits, Change Control
      • Regular Quality Review Meetings
      • Key Performance Indicators
      • Tried and Tested Processes Adapted to Your Work Environment
    • A few of our other very interesting and solicited GMP QA activities are:
      • GMP Compliance Gap Analysis
      • Inspection Preparation
      • Practical Ongoing Compliance Solutions
      • Falsified Medicines Directive (FMD) Compliance
      • Medicinal Product Supply Chain and Transportation Expertise

    Responsible Person for Good Distribution Practices

    “The wholesale distributor must designate a person as Responsible Person (RP). The RP should meet the qualifications and all conditions provided for by the legislation of the Member State concerned. A degree in pharmacy is desirable. The RP should have appropriate competence and experience, as well as knowledge of, and training in GDP. The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices.”

    • Certain dispositions in the royal decree of 14 December 2006 concerning medicines for human and veterinary use are applicable to the wholesale of medicines.
    • On 23 November 2013, the European Union published revised guidelines regarding the Good Distribution Practices (GDP) for medicines for click for more infowhy did i get this?phone waterproof caseelf bar 600 reviewcute phone caseshttp://www.berkeleyiceland.com human use in its official journal. These guidelines entered into force on 5 November 2013. They are applicable to wholesale distribution authorisation holders of medicinal products as well as to manufacturing authorisation holders involved in distribution activities (storage included).
    • The European GDP Guideline of 5 November 2013 requires that wholesale distributors must appoint RP for GDP.

    M.P.C.A. International BV provides RP services performed by pharmacists that are fully trained on a yearly basis to respond to the following duties and responsibilities.

    The duties of a RP include:

    • To ensure that the provisions of the licence are observed;
    • To ensure that the operations do not compromise the quality of medicines;
    • To ensure that an adequate quality system is established and maintained;
    • To oversee audit of the quality system and to carry out independent audits;
    • To ensure that adequate records are maintained;
    • To ensure that all personnel are trained;
    • To ensure full and prompt cooperation with product licence holders in the event of recalls.

    The responsibilities of RP include:

    1. Ensuring that a quality management system is implemented and maintained;
    2. Focusing on the management of authorised activities and the accuracy and quality of records;
    3. Ensuring that initial and continuous training programs are implemented and maintained;
    4. Coordinating and promptly performing any recall operations for medicinal products;
    5. Ensuring that relevant customer complaints are dealt with effectively;
    6. Ensuring that suppliers and customers are approved;
    7. Approving any subcontracted activities which may impact on GDP;
    8. Ensuring that self-inspections are performed at appropriate regular intervals following a pre-arranged program and necessary corrective measures are put in place;
    9. Keeping appropriate records of any delegated duties;
    10. Deciding on the final disposition of returned, rejected, recalled or falsified products;
    11. Approving any returns to saleable stock;
    12. Ensuring that any additional requirements imposed on certain products by national law are adhered to.

    By signing a Technical Quality Agreement for RP with the WDA holder, our clients commit to the following:

    • To carry out their duties, our RPs should have a clear reporting line to the licence holder.
    • A written job description of the responsible person should define their authority to take decisions with regard to their responsibilities.
    • The wholesale distributor should give the RP the defined authority, resources and responsibility needed to fulfil their duties.
    • The RP should have personal knowledge of the products traded under the licence and the conditions necessary for their safe storage and distribution.
    • The RP should have access to all areas, sites, stores and records which relate to the licensable activities and regularly review and monitor all such areas, etc. and the standards achieved.
    • The RP should carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met.
    • The RP should have regularly, at least yearly, access to training facilities and be able to train the staff of the WDA holder on a yearly basis. If no training material is available, training must be foreseen by M.P.C.A. International BV.
    • The RP should fulfil their responsibilities personally and should be continuously contactable. The responsible person may delegate duties, but not responsibilities.

    RP for GDP: Which Duties can be Delegated?

    • The area of responsibility of the Responsible Person for Good Distribution Practice (RP for GDP) is quite extensive. According to Chapter 2.2. of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01), twelve task areas (No. 1 to 12) are covered.
    • Chapter 2.2. states: "The responsible person may delegate duties but not responsibilities." In view of the rather extensive area of responsibility, the question therefore arises which tasks can be delegated if needed and which activities have to be performed personally.
    • An indication of this is the exact wording in the EU GDP Guidelines. For example, the terms "approving" and "deciding" indicate that the task in question must be performed personally.

    Accordingly, the following categorisation can be made:

    • Duties to be Performed Personally
      • Focusing on the management of authorised activities and the accuracy and quality of records;
      • Approving any subcontracted activities which may impact on GDP;
      • Approving any returns to saleable stock;
      • Keeping appropriate records of any delegated duties;
      • Deciding on the final disposition of returned, rejected, recalled or falsified products.
    • Duties that can be delegated
      • Conducting trainings;
      • Carrying out self-inspections;
      • Performing recall operations for medicinal products;
      • Handling of customer complaints;
      • Compliance with additional requirements imposed on certain products by national law.


    Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce their risks and increase their benefits.

    The Good Pharmacovigilance Practices (GVP) modules have been released to facilitate the performance of pharmacovigilance activities.

    M.P.C.A. International BV provides both global and local PV services;

    • We implement a complete pharmacovigilance system into your company and act as EU QPPV or Local Contact Person for BENELUX with access to medical evaluation.
    • Alternatively, we can offer to be responsible for parts of the pharmacovigilance system or act as the Deputy QPPV or Deputy of the Local Contact Person/ Local Safety Officer.

    The complete range of PV Pharmacovigilance Services offered by M.P.C.A. International BV are:

    Pricing and Reimbursement

    Pharmaceutical companies have to deal with a continuously growing number of regulations, directives and requirements imposed by their competent authorities. However, they focus on bringing new and innovative medicinal products more rapidly to the patient. To make this happen, a focused and transparent market access strategy is a must.

    M.P.C.A. International BV is specialised in market access in BENELUX for pharmaceuticals and medical devices.
    Through our extensive network, we work with leading experts in all important strategic therapeutic areas.

    Our market access services are:

    • Strategic counselling
      We guide our clients to the best access route and pricing strategy. We build market access strategies enabling faster patient access to therapies.
    • Price determination
      We prepare and file national pricing dossiers. We set prices for optimal access and returns according to economic and international criteria.
    • Reimbursement
      We prepare and file reimbursement dossiers.

    Public and governmental affairs

    We create a favourable environment in which companies can dedicate their treatments for patients globally through:

    • Shortening duration for market access,
    • Improving reimbursement conditions,
    • Ensuring best pricing conditions considering corporate guidelines.