Market Access & Supply Chain

Market Access & Supply Chain – EU


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.

CEP Applications

PharmSol has rich experience in making applications and following up for CEPs for APIs. Preparation of the data and presentation in the DMF is an art which develops through experience. PharmSol provides a complete solution of CEP, right from application preparation to grant of CEPs. Where needed, inspections can also be triggered.

Dossier Compilation and Review

PharmSol provides complete guidance in compilation of CTD Dossiers. The compilation is preceded by a thorough review of the data and if needed, audits are conducted to ensure data integrity. PharmSol also carries out dossier reviews and guides clients in updating / upgrading the same.

Dossier Submissions

PharmSol provides complete support for making regulatory strategies, submissions of dossiers (DCPs, NPs, and MRPs), being MAA & MAH on behalf of clients, deficiency answering up to grant of MAs in EU. PharmSol can manage these projects on a turnkey basis at optimum costs. PharmSol can also handle variation procedures with innovative strategies.

Pharmacovigilance

Pharmacovigilance is an essential part of regulatory submissions. PharmSol provides a comprehensive solution in this area through one of its network partners, who are a global leader in this field.

MA Holding

For regulatory submissions in EU, one needs to have a company with GMP and PV infrastructure in EU, who can be designated a MAA and MAH. PharmSol subsidiaries in Malta as well as Germany can be the MAH on behalf of clients.

EU Importation & Batch Control / Batch Release

PharmSol setups in Malta and Germany are capable of carrying out Import, Batch Control and Release of Products in EU. Both Germany and Malta offer different strategic and regulatory advantages as well.

Market Access & Supply Chain – GCC


PharmSol MPCC LLC, Dubai is a company dedicated to represent, register, market and distribute Pharmaceutical and Allied Products in the GCC /MENA region. The following services are offered by PharmSol MPCC LLC:

Local Agent for Foreign Manufacturers

With a Drug Store set up in Dubai, PharmSol MPCC LLC acts as an agent to represent foreign manufacturers in the GCC region and facilitate the entire process of registering and marketing the products in the GCC region.

Registration of Companies and Products

PharmSol MPCC LLC has a dedicated team of regulatory personnel with hands on experience in GCC registration procedures. PharmSol also carries out third party dossier reviews, which helps in curtailing the regulatory process.

GCC Inspection Guidance

PharmSol team offers guidance to its clients in preparing for GCC inspections. PharmSol also conducts pre-inspection audits of the foreign manufacturer’s facilities.

Pharmacovigilance Services

Pharmacovigilance is now a legal requirement for all product registrations and marketing authorizations. This requires a full time certified PV Officer, for which PharmSol has dedicated staff.

Import, Storage and Distribution

PharmSol MPCC LLC imports and supplies the products in the GCC region. PharmSol also has strong ties with several leading distributors in the region.

Facility Design and Upgradation in the GCC / MENA Region

One of the key activities of PharmSol is to provide guidance in designs and upgradation of facilities in line with the requirements of GCC and International regulatory authorities. PharmSol is currently involved in several such assignments in the region. PharmSol adds value by its international expertise of GMP in combination with GEP. As part of facility upgradation, PharmSol also provides guidance in designing and instituting robust QMSs in manufacturing facilities.

Product In-licensing and Tech Transfer

PharmSol, with its network in Europe and US, provides valuable assistance in in-licensing and tech transfer of Products to the local manufacturing sites.

Compliance Management
(Vendor Qualifications, GMP Audits, GDP Audits, Training)

PharmSol conducts third party GMP audits of all vendors who supply their RMs to manufacturers in GCC, as part of their QMS obligations. In addition, PharmSol provides GMP trainings in the region.

Market Access & Supply Chain – EU


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.

CEP Applications

PharmSol has rich experience in making applications and following up for CEPs for APIs. Preparation of the data and presentation in the DMF is an art which develops through experience. PharmSol provides a complete solution of CEP, right from application preparation to grant of CEPs. Where needed, inspections can also be triggered.

Dossier Compilation and Review

PharmSol provides complete guidance in compilation of CTD Dossiers. The compilation is preceded by a thorough review of the data and if needed, audits are conducted to ensure data integrity. PharmSol also carries out dossier reviews and guides clients in updating / upgrading the same.

Dossier Submissions

PharmSol provides complete support for making regulatory strategies, submissions of dossiers (DCPs, NPs, and MRPs), being MAA & MAH on behalf of clients, deficiency answering up to grant of MAs in EU. PharmSol can manage these projects on a turnkey basis at optimum costs. PharmSol can also handle variation procedures with innovative strategies.

Pharmacovigilance

Pharmacovigilance is an essential part of regulatory submissions. PharmSol provides a comprehensive solution in this area through one of its network partners, who are a global leader in this field.

MA Holding

For regulatory submissions in EU, one needs to have a company with GMP and PV infrastructure in EU, who can be designated a MAA and MAH. PharmSol subsidiaries in Malta as well as Germany can be the MAH on behalf of clients.

EU Importation & Batch Control / Batch Release

PharmSol setups in Malta and Germany are capable of carrying out Import, Batch Control and Release of Products in EU. Both Germany and Malta offer different strategic and regulatory advantages as well.

Market Access & Supply Chain – GCC


PharmSol MPCC LLC, Dubai is a company dedicated to represent, register, market and distribute Pharmaceutical and Allied Products in the GCC /MENA region. The following services are offered by PharmSol MPCC LLC:

Local Agent for Foreign Manufacturers

With a Drug Store set up in Dubai, PharmSol MPCC LLC acts as an agent to represent foreign manufacturers in the GCC region and facilitate the entire process of registering and marketing the products in the GCC region.

Registration of Companies and Products

PharmSol MPCC LLC has a dedicated team of regulatory personnel with hands on experience in GCC registration procedures. PharmSol also carries out third party dossier reviews, which helps in curtailing the regulatory process.

GCC Inspection Guidance

PharmSol team offers guidance to its clients in preparing for GCC inspections. PharmSol also conducts pre-inspection audits of the foreign manufacturer’s facilities.

Pharmacovigilance Services

Pharmacovigilance is now a legal requirement for all product registrations and marketing authorizations. This requires a full time certified PV Officer, for which PharmSol has dedicated staff.

Import, Storage and Distribution

PharmSol MPCC LLC imports and supplies the products in the GCC region. PharmSol also has strong ties with several leading distributors in the region.

Facility Design and Upgradation in the GCC / MENA Region

One of the key activities of PharmSol is to provide guidance in designs and upgradation of facilities in line with the requirements of GCC and International regulatory authorities. PharmSol is currently involved in several such assignments in the region. PharmSol adds value by its international expertise of GMP in combination with GEP. As part of facility upgradation, PharmSol also provides guidance in designing and instituting robust QMSs in manufacturing facilities.

Product In-licensing and Tech Transfer

PharmSol, with its network in Europe and US, provides valuable assistance in in-licensing and tech transfer of Products to the local manufacturing sites.

Compliance Management
(Vendor Qualifications, GMP Audits, GDP Audits, Training)

PharmSol conducts third party GMP audits of all vendors who supply their RMs to manufacturers in GCC, as part of their QMS obligations. In addition, PharmSol provides GMP trainings in the region.