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We offer specialized consultancy services to small pharmaceutical and biotech companies that are in the process of developing their quality management systems. Our experienced QA specialists provide guidance on the establishment and adaptation of your quality framework, ensuring it aligns with your stage of development and specific needs. This approach ensures scalability without introducing unnecessarily complex solutions.
As part of our service portfolio, we offer flexible consulting services, including full-time GMP-experienced consultants and tailored advisory support. In addition, we help ensure compliance with all supplier audit requirements and can design a flexible audit package with a strong focus on cost-effectiveness.
Repackaging may be required when updating labels, revising text, adapting language versions, or making changes to secondary packaging. We offer flexible and scalable repackaging solutions that ensure your products are ready for customers and business partners.
Our Qualified Person (QP) can certify and release products to market in compliance with applicable regulations in Denmark, the EU, and globally. We manage the entire documentation process, including SOPs and quality agreements, to ensure transparency and regulatory compliance.
At our facility in Herlev, we have the capacity to carry out repackaging activities with the option of simultaneous market release. If you have products that must be stored and handled under GMP conditions, we offer a complete solution in which our trained GMP technicians oversee the repackaging process as well as the associated logistics surrounding import, distribution, labeling, and the delivery of batch documentation.
We hold all necessary regulatory authorizations and handle secondary packaging and labeling with full traceability and robust quality assurance.
We guide you every step of the way - from import and regulatory approvals to distribution.
We offer a complete solution for handling pharmaceuticals, medical devices, APIs and IMPs – from import and transport to goods receipt inspection, storage and batch release in accordance with EU-GMP. Our services also include repackaging, clinical final packaging, labelling and distribution to wholesalers and clinical departments. With our fully documented and qualified systems, we ensure that storage, handling and distribution are carried out in accordance with applicable cGMP guidelines.
At our GMP facilities in Herlev, we offer safe and efficient storage at 15–25 degrees celsius, where we meet the market’s highest standards for quality and safety. In addition, we offer destruction as well as outsourcing of complaints handling, pharmacovigilance and other regulatory services, giving you a flexible and compliant solution tailored to your needs.
We offer audit services that ensure your suppliers and partners comply with applicable standards. In addition to being a regulatory requirement, audits provide a guarantee of high quality and compliance.
Audits can be carried out both remotely and on-site in Denmark and Europe, while outside Europe we offer audits through approved local partners. We can audit according to standards such as EU GMP, ISO 13485, and others.
Audits are an integral part of GMP quality and an important tool for ensuring that suppliers meet the correct specifications. As no two audits are the same, we adapt the process to your needs and review all relevant quality parameters in close collaboration with you. In addition, we offer a risk assessment of your audit needs to optimise the use of resources and ensure compliance in the most effective way.
Herlev Pharma Service er et konsulenthus der supporterer mindre medicinal- og biotek-virksomheder med at komme i compliance, med udgangspunkt I størrelse, ambition og målsætning. Vores danske facilitet er centralt placeret I Storkøbenhavn og opfylder alle kvalitetskrav og inspiceret regelmæssigt af Lægemiddelstyrelsen. Vores konsulenter har erfaring med at varetage og udvikle kvalitetsprocesser I mindre virksomheder og vi kan håndtere jeres produkter i vores godkendte facilitet.
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Vi tilbyder rådgivning som en naturlig del af vores serviceudvalg. Hos Herlev Pharma Service tilbyder vi to typer rådgivningstjenester, der er skræddersyet til at understøtte din virksomheds behov: fuldtids GMP-erfarne konsulenter og skræddersyede rådgivningstjenester.
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Vi tilbyder en omfattende service til opbevaring af jeres lægemidler, medicinsk udstyr, API og IMP’s, der håndteres sikkert og effektivt I vores GMP-områder i Herlev. Med vores fuldt dokumenterede og kvalificerede systemer sikrer vi opbevaring, håndtering og distribution I overensstemmelse med gældende guidelines (cGMP). Vi tilbyder opbevaring ved 15-25 grader og lever op til markeds højeste standarder for sikkerhed.
Læs mere
I vores facilitet I Herlev har vi kapacitet til ompaknings opgaver, samt mulighed for samtidig frigivelse til markedet. Har du et parti produkter som skal opbevares og håndteres under GMP tilbyder vi at tage al håndteringen, og med vores trænede GMP teknikere kan vi sikre ompakningsprocessen samt logistikken omkring import, distribution, etikettering, samt levering af batch dokumention. Vi har alle relevante tilladelser. (link til myndighedsgodkendelser). Vi håndterer ompakning af sekundær emballage og labelling.
Vi udfører audit for jer hos jeres kritiske leverandører, samarbejdspartnere og sikrer jer, at de overholder gældende standarder. Ud over at være et myndighedskrav, giver et audit sikkerhed for at kvaliteten er i top. Et audit kan gennemføres på mange måder, men det afgørende er at vi udfører det efter jeres behov - både remote og on site i Danmark eller Europa. Udenfor Europa kan vi også tilbyde audits gennem godkendte samarbejdspartnere. Vi kan auditere indenfor EU GMP, ISO 13485, etc.
