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PharmSol – Fertigung

Global pharmaceutical service provider for Regulatory Affairs, GMP Compliance, Audits, CDMO Services and Supply Chain

PharmSol Logo

PharmSol Group (Pharmaceutical Solutions DMCC)

Dubai (AE) · Bad Oldesloe (DE) · Nanjing (CN) · Hong Kong (CN) · Hyderabad (IN) · Mosta (MT)New on Amplifa

2004Founded
51-200Employees
6Locations worldwide
220+Successful solutions
77+Tech Transfers

About PharmSol

Founded in 2004, PharmSol is a global pharmaceutical service provider headquartered in Dubai (Jumeirah Lakes Towers). The company offers integrated solutions through a single point of contact ('single window') for pharmaceutical and biotech customers as well as generics manufacturers. The service portfolio covers GMP/QP audits, EU GMP certification, USFDA compliance, Regulatory Affairs & Market Access, biosimilar development, facility design and project management, sourcing & supply chain, and Contract Development & Manufacturing (CDMO) for APIs and finished dosage forms (FDFs). PharmSol works with a worldwide network of manufacturers and supports technology transfers, approvals and product supply, including in patent-free territories. Locations exist in Dubai, Bad Oldesloe (Germany), Nanjing and Hong Kong (China), Hyderabad (India) and Mosta (Malta). Customers include, among others, Caelo (Caesar & Loretz GmbH) and Sasha.

Site
Dubai
Processes
Contract Development & Manufacturing (CDMO) of pharmaceutical products, Technology Transfer, GMP/QP Audits, EU GMP Certification, Regulatory & Market Access, USFDA Compliance & Regulatory, Compliance Solutions, Biosimilar Development (End-to-End)
Materials
APIs (Active Pharmaceutical Ingredients), FDFs (Finished Dosage Forms), Biosimilars, Medical Devices, Dietary Supplements
Certificates
APIC/CEFIC/ASQ Certified Auditors (Team Certification), APIC/CEFIC/ASQ Certified Auditors (Team)
Founded
2004
Employees
51-200
Industries
Pharmaceutical Industry, Biotech, Generics Manufacturers
  1. 01

    Product Development (APIs/FDFs)

  2. 02

    Regulatory & Approvals

  3. 03

    Technology Transfer

  4. 04

    Contract Development & Manufacturing

  5. 05

    Sourcing & Supply Chain

  6. 06

    GMP Compliance & Audits

Products & Development Objects

API

APIs (Active Pharmaceutical Ingredients)

Development, approval and supply of pharmaceutical active ingredients.

FDF

FDFs (Finished Dosage Forms)

Development and licensing of finished dosage forms via a global manufacturing network.

BIO

Biosimilars

End-to-end support from development to marketing of biosimilars.

MD

Medical Devices

Development, manufacturing and supply of medical devices.

SUPP

Dietary Supplements

Development and supply of dietary supplements.

Locations

Standort Dubai

Dubai

AE

Headquarters (Jumeirah Lakes Towers, Tiffany Tower)

Bad Oldesloe

DE

Branch Office (Brunnenstr. 1)

Nanjing

CN

Branch Office (Jiangning District, Future Science and Technology City)

Hyderabad

IN

Branch Office (Madhapur, Hitech City)

Mosta

MT

Branch Office (Valletta Road, The Victoria Centre)

Hong Kong

CN

Branch Office (Connaught Road Central)

Services & Product Areas

GMP/QP Audits
GMP/QP AuditsAudits · Pharmaceutical Industry
EU GMP Certification
EU GMP CertificationCompliance · Generics Manufacturers
Regulatory & Market Access
Regulatory & Market AccessApprovals · Biotech
USFDA Compliance
USFDA ComplianceRegulatory · Pharmaceutical Industry

Inside the production

Regulatory Services
Regulatory Services
Product Portfolio
Product Portfolio

Industries

Pharmaceutical IndustryBiotechGenerics Manufacturers

Processes & technical limits

ProcessesToleranceMax. partWeightLot sizeMaterials
Contract Development & Manufacturing (CDMO) of pharmaceutical productsEngineering––––APIs, FDFs
Technology TransferEngineering–––––
GMP/QP AuditsTesting–––––
EU GMP CertificationTesting–––––
Regulatory & Market AccessEngineering–––––
USFDA Compliance & RegulatoryTesting–––––
Compliance SolutionsTesting–––––
Biosimilar Development (End-to-End)Engineering–––––
Facility Design & Project ManagementEngineering–––––
Sourcing & Supply ChainAssembly–––––

Additional services

GMP/QP AuditsEU GMP CertificationRegulatory & Market AccessUSFDA Compliance & RegulatoryComplianceBiosimilar DevelopmentFacility Design & Project ManagementSourcing & Supply ChainLicensing & SupplyCo-DevelopmentsTech TransferContract Development & Manufacturing (CDMO)Product Development (APIs and FDFs)IPRQualificationsDossiersQMSPharmacovigilanceComputer System ValidationGDP

Reference customers

Caelo (Caesar & Loretz GmbH)Sasha

Quality & Compliance

PharmSol deploys a team of APIC/CEFIC/ASQ-certified auditors and maintains an extensive audit library. The experts support customers on-site with compliance preparation for authority inspections such as USFDA, EU and TGA.

EvidenceDubai
APIC/CEFIC/ASQ Certified Auditors (Team)

History

  1. 2004

    Founding of PharmSol

  2. 2025

    Participation in CPHI Frankfurt

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