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 market.
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, documented manufacturing, quality systems and regulatory support in one coordinated workflow. We work as a long-term partner, helping clients move efficiently from concept and pilot work to production and market readiness.
Contract manufacturing
Full-Service Contract Manufacturing for Health & Wellness Products
We provide contract manufacturing services for pharmaceutical products, nutritional supplements, medical devices, FSMPs and cosmetics, with processes designed around compliance, consistency and documentation.
Development-to-Production Support
We support both ready-to-produce formulas and custom development projects. Depending on product requirements, we can assist with pilot batches, small-batch manufacturing and industrial-scale production, coordinated with QA/QC and Regulatory Affairs.
What Our Partners Value
- Traceable production workflows
- Clear documentation for audits and registrations
- Cross-functional collaboration between R&D, Quality and Regulatory
- A flexible, science-driven partner for long-term cooperation
Manufacturing Facilities
Controlled, Safe and Traceable Operations
Our production facilities are designed for safe, consistent and traceable manufacturing, with controlled environments and monitored systems for temperature, humidity and positive air pressure.
Clean Zones and Process Control
Manufacturing and packaging take place in controlled areas operating under laminar flow conditions, helping reduce contamination risk and support reproducible batch performance across different product forms.
Current Product Forms
- Oral liquids, syrups and sprays
- Creams, emulsions and gels for topical, rectal, vaginal and dental use
Production is supported by documented procedures, continuous monitoring and end-to-end batch traceability.
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. Development work is coordinated with production, QA/QC and Regulatory Affairs from an early stage to help shorten the path to market.
R&D Services
- Selection of actives and trusted suppliers
- Formulation development and optimization
- Pilot and industrial-scale trial batches
- Analytical method development and validation
- ICH stability studies
- Technical documentation and CTD dossier support
Areas of Focus
- Pharmaceutical and OTC products
- Nutraceuticals and nutritional supplements
- Medical devices
- FSMPs and special nutritional products
- Cosmetics
Quality control
Control, Documentation and Release Confidence
Quality Control is integrated into the production workflow to help ensure that raw materials, in-process samples and finished products meet predefined specifications for quality, consistency and purity.
QC Activities
- Raw material and packaging material controls
- In-process checks throughout manufacturing
- Final product testing, including physical-chemical, microbiological and sensory evaluation where applicable
- Stability testing, documented analytical procedures and traceable records
- Continuous training and controlled documentation
Quality Framework
Our quality framework is supported by current certifications including ISO 9001:2015, ISO 13485:2016 and ISO 22716:2007.
Regulatory Affairs
Regulatory Support from Development to Market
Our Regulatory Affairs team supports products intended for Greece and other markets, working closely with development and manufacturing so documentation is built in parallel with the technical work.
Regulatory Support Services
- Regulatory strategy for national, EU and selected export markets
- Technical documentation and CTD dossier preparation
- Product technical file organization and review
- Documentation aligned with applicable GMP, ISO and product-specific requirements
- Stability data, validated methods and product technical profiles
- Support during audits, inspections and licensing procedures
What This Means for Clients
Regulatory work is integrated into the project from the start, helping reduce delays and improve readiness for registration and launch.
Environmental management
Environmental Responsibility in Daily Operations
Environmental management is part of the way we operate. We focus on responsible resource use, waste reduction and environmental awareness across our activities.
Our Approach
- Responsible management of recyclable materials and packaging
- Efficient use of energy and infrastructure
- Reduction of waste and unnecessary emissions
- Staff awareness and continuous improvement
We view environmental responsibility as part of long-term operational discipline and product stewardship.
Quality Assurance / QA
Quality Is Built Into the Process
Our QA system supports all stages of activity, from raw material control to production, storage, distribution and documentation review, helping ensure that each project is handled under controlled procedures.
Documented Quality System
- Quality manuals and controlled procedures
- Standard Operating Procedures (SOPs)
- Batch documentation and release checkpoints
- Internal audits and periodic system review
- Continuous improvement through measurable quality targets
Quality Standards
Our quality system is supported by documented procedures, GMP-based operational controls and current certifications including ISO 9001:2015, ISO 13485:2016 and ISO 22716:2007.
From development to launch, quality is designed, documented and verified.
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