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We offer specialized consultancy services to smaller pharmaceutical and biotech companies that are in the process of developing their quality setup. Our experienced QA specialists provide guidance on building and adapting your quality structure to match your stage of development and needs. This ensures scalability without unnecessary complex solutions.
As part of our service offering, we provide flexible consulting services, including full-time GMP-experienced consultants and tailored advice. Additionally, we assist in ensuring compliance with all requirements for audits of subcontractors, and we put together a flexible audit package with a focus on cost-effectiveness.
REPACKAGING & RELEASE
Repackaging may be necessary for label updates, text changes, language adjustments, or alterations to outer packaging.
We offer flexible and scalable repackaging solutions that ensure your products are ready for customers and partners.
Our Qualified Person (QP) can release products to the market in compliance with applicable regulations in Denmark, the EU, and globally. We handle the entire documentation process, including SOPs and quality agreements, to ensure transparency and compliance.
In our facility in Herlev, we have the capacity to perform repackaging tasks with the possibility of simultaneous market release. If you have products that need to be stored and handled under GMP conditions, we offer a comprehensive solution where our trained GMP technicians ensure the repackaging process, as well as logistics around import, distribution, labeling, and delivery of batch documentation.
We hold all necessary regulatory approvals and handle repackaging of secondary packaging and labeling with full traceability and quality assurance.
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We offer a complete solution for the handling of pharmaceuticals, medical devices, APIs, and IMPs – from import and transport to goods receipt inspection, storage, and batch release in compliance with EU-GMP.
Our services also include repackaging, clinical final packaging, labeling, and distribution to wholesalers and clinical sites. With our fully documented and qualified systems, we ensure that storage, handling, and distribution are carried out in compliance with applicable cGMP guidelines.
At our GMP facilities in Herlev, we provide secure and efficient storage (at 15-25°C), meeting the highest market standards for quality and safety. Additionally, we offer destruction services, as well as outsourcing of complaint handling, drug monitoring, and other regulatory services, ensuring a flexible and compliant solution tailored to your needs.
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We offer audit services that ensure your suppliers and partners comply with applicable standards. In addition to being a regulatory requirement, audits provide assurance of high quality and compliance.
Audits can be conducted both remotely and on-site within Denmark and across Europe. For locations outside Europe, we offer audits through approved local partners. We can audit according to standards such as EU GMP, ISO 13485, and more.
Audits are an integral part of GMP quality assurance and a crucial tool to ensure that suppliers meet the required specifications. Since no two audits are alike, we tailor the process to your specific needs and assess all relevant quality parameters in close collaboration with you. In addition, we offer a risk assessment of your audit requirements to optimize resource usage and ensure compliance in the most efficient 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.
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.