From Biocant Park @Cantanhede, Portugal, to the world!
Wherever you have a need, we will be there to assist you. Compliance is needed everywhere, regardless of the market. From licensing your company’s activities and developing your product to its placement and maintenance in the market.
Remote and on-the-job consulting.
We are freelance experts, specialized in regulatory affairs and quality assurance.
Our passion lies in supporting the growth of companies and businesses in the medicinal and health product (medical devices and cosmetics) and food supplement sectors, supported by good practices, compliance with legal requirements, fit-to-need fulfillment of customer needs and creation of added value solutions.
We are here to help you!
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Flexibility
Years of Experience
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Focus on Client
Featured Services
CE Marking and Medical Devices Documentation
Total Regulatory Compliance of Medical Devices
Support to Food Supplement Companies
Fit-to-need Solutions for your Business
Outsourcing of Specially Qualified Job Functions
Person Responsible for Regulatory Compliance (PRRC);
Medical Devices Authorised Representative (EC-REP);
Pharmaceutical Technical Direction /Technical Responsibility;
Pharmacovigilance (EU-QPPV, Deputy QPPV, QPPV’s Medical Advisor, LCPPV/LSO);
Cosmetic Safety Assessor; Quality Manager;
HACCP Responsible Person.
CE Marking and Medical Devices Documentation
Develop Quality Management System documentation and Technical Files, including post-market surveillance (PMS), tailored to your needs and your devices, to reach MDR 2017/45 and EN ISO 13485 compliance. CE marking project management. UDI compliance and documentation.
Total Regulatory Compliance of Medical Devices
Contacts with competent authorities and notified bodies, licensing projects for manufacturing and distribution activities, EUDAMED and national databases registration.
Support to Food Supplement Companies
Notification of new products in EU member states and international markets, free sales certificates, maintenance of product lifecycle, interactions with competent authorities (e.g. in Portugal: DGAV, CIAV and ASAE), labeling assessment, assessment and advice on nutrition and health claims, audits and monitoring of inspections, SIPACE registration, regularization of manufacturing and distribution activities, regulatory intelligence, implementation and audits of HACCP systems and ISO 22000.
Fit-to-need Solutions for your Business
Temporary replacement of employees on parental leave or other prolonged absences, audits of MAA and registration dossiers, due diligence of promotional materials (medicinal products, medical devices, cosmetics and food supplements), management of in/out-licensing projects, advice on the development of new products, submission and management of MAA and variations to medicines, bibliographic research, technical translations.
Outsourcing of Specially Qualified Job Functions
Person Responsible for Regulatory Compliance (PRRC); Medical Devices Authorised Representative (EC-REP); Pharmaceutical Technical Direction /Technical Responsibility; Pharmacovigilance (EU-QPPV, Deputy QPPV, QPPV’s Medical Advisor, LCPPV/LSO); Cosmetic Safety Assessor; Quality Manager; HACCP Responsible Person.
Blog
Breaking Down Notified Bodies’ Standard Fees: What You Need to Know
The European Commission's Medical Device Coordination Group (MDCG) has issued...
Extension of the EU MDR transition period – Recent Developments
With EU Members arguing legislative measures had to be put forward to help...
What you need to know – UDI in the MDR
The new Medical Device Regulation 2017/745 (MDR) changed and introduced...
