About us
Who We Are
Sikalias Pharmaceutical Laboratories is a Greek development and manufacturing partner for health and wellness products. We support pharmaceutical, nutraceutical, medical device, FSMP and cosmetic companies that need a reliable path from development to industrial-scale manufacturing.
Our Background
Our activity is built on a pharmacy and formulation heritage that began in Peristeri in 1967 and has evolved into a modern laboratory operation focused on quality, traceability and practical product development.
Our Approach
We combine formulation development, analytical development, stability studies, technical documentation generated through development and documented manufacturing in one coordinated workflow.
Where product registration work is required, we work in coordination with the client’s appointed regulatory office and/or MAH partner, helping clients move efficiently from concept and pilot batches to industrial scale-up and market readiness.
Contract manufacturing
Contract Manufacturing for Health & Wellness Products
We provide contract manufacturing services for pharmaceuticals, food supplements, medical devices, FSMPs and cosmetics, with emphasis on compliance, consistency and documentation.
Development-to-Production Support
Our role may start from the client brief and continue through formulation development, analytical development, stability studies, pilot batches, process transfer and industrial-scale manufacturing.
Our operating model is designed to support both development-driven or smaller campaigns and larger commercial batches, with greater flexibility in batch size and stronger continuity of supply for our clients.
What Our Partners Value
- Traceable production workflows
- Clear documentation for audits, tech transfer and manufacturing-readiness reviews
- Cross-functional collaboration between R&D, Quality and Manufacturing
- A flexible, science-driven partner for long-term cooperation
How a Typical Project Works
Client brief → Formulation development → Analytical development → Stability studies → Pilot batches → Process transfer → Industrial scale-up → Technical package handover → Manufacturing
Facilities & Two-Site Operating Model
Two Sites, One Integrated Development and Manufacturing Platform
Our operating model is built around two complementary sites in Peristeri.
The Kyklaminon 7 site supports R&D, analytical work, pilot support, QC and GMP operations for specific non-sterile human pharmaceutical and investigational formats, together with batch certification, packaging support and chemical / physical quality control.
The Stylianou Gonata 3-5 site, in the Peristeri Industrial Area, expands the company’s industrial manufacturing platform with larger GMP lines and with a broader authorized dosage-form scope across human pharmaceuticals, investigational pharmaceuticals, food supplements, medical devices and cosmetics.
Together, the two sites support more efficient transfer from development to manufacturing, greater batch-size flexibility and stronger continuity of supply.
Manufacturing capabilities & Technical platform
Authorized dosage-form scope
Depending on product category and project requirements, our manufacturing platform supports:
- External-use liquids: dermal solutions, pharmaceutical soaps, emulsions
- Internal-use liquids: oral sprays, oral solutions, syrups, suspensions, oral drops
- Nasal solutions and nasal sprays
- Otic drops
- Semi-solids: creams, ointments, gels
- Tablets: plain, effervescent, lozenges, coated
- Hard capsules
- Powders and effervescent powders in sachets
Technical features that enhance quality and flexibility
- Low-humidity operations with the ability to go below 10% RH for moisture-sensitive or hygroscopic formulations and for selected solid-dose applications
- Powder filling into bottles for products intended for reconstitution into suspensions
- Solid-dose packaging in PVC/Alu blisters, Alu/Alu strips or bottles
- Automated lines for nasal solutions / sprays and oral sprays, from mixing through primary and secondary packaging, with minimized direct manual handling
- Automated packaging line for otic drops
- Automated packaging line for oral solutions, syrups and suspensions
- Nitrogen capability for formulations containing oxidation-sensitive ingredients
This combined platform supports projects that are not easily handled by less flexible facilities, while strengthening both manufacturing quality and operational security for our clients.
Research and Development
Evidence-Based Innovation – Value-Driven R&D
Our R&D team develops formulations that are scientifically sound, technically robust and commercially relevant.
Our role typically starts from the client brief and continues through formulation development, analytical development, stability studies, pilot work and technical package generation.
Our two-site model allows efficient transfer from development into the most appropriate manufacturing environment depending on dosage form, process requirement, batch size and supply strategy.
R&D Services
- Brief assessment and formulation strategy
- Lab-scale formulation development and optimization
- Analytical method development and validation
- ICH stability studies
- Pilot and industrial-scale trial batches
- Technical development package to support dossier preparation by the client’s appointed regulatory office
- Scale-up support and technical handover to manufacturing
Areas of Focus
- Pharmaceutical and OTC products
- Nutraceuticals and nutritional supplements
- Medical devices
- FSMPs and special nutritional products
- Cosmetics
Technical Documentation & Regulatory Compliance Support
Compliance Support from Development to Manufacturing
Our regulatory-compliance function is integrated within QA and focuses on the technical documentation and factory-side compliance support required for development, scale-up and manufacturing.
Sikalias Pharmaceutical Laboratories operates as a contract development and manufacturing partner. For registration projects, we work in coordination with the client’s appointed regulatory office and/or MAH structure rather than acting as the owner of the product’s regulatory pathway.
Support Scope
- QA-led review of documentation and compliance requirements
- Technical product documentation generated through development
- Manufacturing and scale-up documentation aligned with applicable GMP, ISO and product-specific requirements
- Stability data, analytical data and technical product profiles
- Support during audits, inspections, tech transfer and manufacturing-readiness reviews
- Coordination with client-appointed regulatory partners where required
What This Means for Clients
Development, documentation and manufacturing remain aligned from the start, while regulatory ownership stays correctly positioned with the client’s appointed RA / MAH structure.
Current Quality Framework
Our quality framework is supported by current certifications including ISO 9001:2015, ISO 13485:2016 and ISO 22716:2007, together with GMP-based operational controls and documented quality procedures.
Get in Touch with Us
We are always open to new collaborations, evaluating your idea, or recommending the best solutions to fit your needs. Reach out to us by phone, email, or by filling out the contact form.
7 Kyklaminon str. Peristeri,
TK12137 Athens - Greece, Head Office & Manufacturing Facility
3-5 Stilianou Gonata str,
ΤΚ12133, Peristeri Industrial Park Unit
Tel +30 210 5720900 info@sikalias.com