services

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 900 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

Balzan, 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