GMP/QP Audits
PharmSol carries out a complete chain of audits which assures product safety and quality to clients across the globe for Finished Products, APIs, Intermediates and Key Starting Materials (KSMs). PharmSol has in-house team of Auditors who are accredited with various certifications including APIC/CEFIC/ASQ CQA/IRCA. PharmSol is one of the first companies to have conducted third party GMP audits for its European clients in compliance with EC Directive 2004/27/EC. PharmSol has successfully conducted over 1,000 GMP audits across the globe.
Compliance
PharmSol does not limit itself only to offering Audits, we expand our solution offerings to ensure complete Compliance at Client’s site. Towards obtaining GMP Certification from Europe or United States or WHO, PharmSol has a very effective, systematic and rationale approach in providing solution efficiently. PharmSol operates on a turnkey basis and gets involved completely ensuring success to its clients, which is the overall objective.
USFDA Compliance & Regulatory
Preparing for a USFDA Inspection and managing the post inspection situation requires a high level of expertise and PharmSol offers a comprehensive solution in that direction.
Product Development
PharmSol operates as a single window service provider for clients across the Globe, taking care of every aspect of the project management in the following areas...
Regulatory & Market Access
With the growth in pharma manufacturing capability in Asia, each manufacturer nurtures an ambition to have their own footprint in the EU market. PharmSol, with its own setups in Germany and Malta, has created a platform which provides a comprehensive, integrated and seamless market access and supply chain solution with the needed infrastructure for FDFs, APIs and Allied Products, right from the site of manufacture to the end point of the distribution chain in compliance with EU GDP guidance and on a cost-effective basis.
Sourcing & Supply Chain
Finding a right source meeting your desired specifications, compliance, expectations and commercial viability is a challenge.
Facility Design & Project Management
PharmSol provides end-to-end solutions right from facility conceptual engineering design to successful commissioning of facility with requisite international regulatory approvals like EUGMP, TGA, PIC/s, etc. Solutions provided are based on the principles of GEP & GMP. The rich experience of Team PharmSol inherently ensures Economics of Design (CAPEX & OPEX), Efficient & Lean Process Operations, Ease of Maintainability, Flexible Plant Operation Philosophy (multi-product manufacturing) & Sustainable Compliance with Optimal Investments.
Our Establishments
PharmSol GmbH
Bad Oldesloe, Germany
PharmSol Europe Limited
Mosta, Malta
Pharmaceutical Solutions FZCO
Jebel Ali, Dubai, United Arab Emirates
Pharmaceutical Solutions DMCC
Jumeirah Lakes Towers, Dubai, United Arab Emirates
PharmSol India Pvt. Ltd.
Hyderabad, India
PharmSol (Nanjing) Pharmaceutical Technology Co.Ltd
Nanjing City, Jiangsu Province, PR China
PharmSol APAC Limited
Hong Kong, China