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.

The following services are integral to the Market Access solution of PharmSol.

• DMF Preparations/Submissions
• Dossier Preparations/Submissions
• Pharmacovigilance
• MA Holding
• EU Importation & Batch Control / Batch Release
• Scientific Advice

BREXIT Support

As the deadline moving closer to the Brexit (UK’s exit from EEA) it is time for clients to take necessary steps towards such situations and make sure to be prepared to face the outcome. PharmSol is well equipped to support clients for post-Brexit scenario and our expertise covers all aspects of regulatory affairs, compliance, supply chain and pharmacovigilance.

Subject Matter Experts of PharmSol can support clients through:

• Identifying the Gaps
• Understanding the key concern areas
• Defining strategy
• Extended support for closing the Gaps

Interested ? Know More ? Kindly Contact Us

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