ahemdabad1
Welcome to Fisher Clinical Services, Ahmedabad, the only facility in the Asia Pacific with EU GMP certification to support Sponsors manufacturing in India. This facility is also fully audited and approved by the European Regulatory Authority for clinical trial packaging. Strategically located in a Free Trade Zone, multinational and local pharmaceutical and biotech sponsors select Fisher Clinical Services Ahmedabad as the partner of choice in this region.

We provide a breadth of services that streamline the clinical supply chain, from blinding to primary and secondary packaging, comparator sourcing, labeling, storage and distribution of clinical supplies (importation and exportation), all the way through to destruction. Find out more about our facility and the benefits extended to Sponsors – a one-stop shop for clinical supply needs. We invite you to read our case studies and to view our video.”

Neeru Madan, General Manager, Fisher Clinical Services, Ahmedabad

 

Fast Facts on the Healthcare Industry:

  • Pharmaceutical Market – $4.5 Billion growing @8-9% p.a.
  • Healthcare Market – Expected to grow to $31.6 Billion in 2020
  • Clinical Research Market – USD 400m in 2012, expected to be USD 500m in 2014
  • GCP Trained Principal Investigators – 900+
  • India’s current market share in Global Clinical trials – 1.4%
ahmedabad-about
India’s first Western-owned clinical supplier.

Ahmedabad Fast Facts:
Location: Western India; One hour north of Mumbai by Air
Population: 7.8 million
Nearest Airport: Sardar Vallabhbhai Patel International Airport (AMD)
Distance from Airport to Facility: Ahmedabad airport is 50 Km from facility.
Fun Fact: Founded in 1411, and one of the older well know cities in India, Ahmedabad was once famous for its textile industry base and was nicknamed Manchester of the East.

City:
Ahmedabad
Country:
India
Opened:
2008
Total Capacity:
3,012 m2
Primary Rooms:
6
Secondary Rooms:
7
Cold Production Rooms:
2
Warehouse Capacity:
16,857 m3
Ambient Storage Capacity:
11,374 m3
Refrigerated Storage Capacity (2-8):
1,215 m3
Frozen Storage Capacity (-20):
84 m3
Controlled Drug Ambient Storage Capacity:
12 m3
Controlled Drug Storage Capacity (Refrigerated):
9 m3
Environmental Technologies:
Yes
Audited:
MHRA 2009, QP 2012, EU GMP 2015
Comparator Sourcing:
Yes
Manufacturing:
Yes (over-encapsulation only)
Returns & Destruction:
Yes
Labeling
Yes
ahmedabad-benefits
Key Benefits for Sponsors:

  • Strategically located in a Free Trade Zone/ SEZ
  • The only purpose built, state of the art, MHRA and CGMP compliant facility in the region
  • The only EU GMP certified facility for packaging, setting best practice standards in India
  • Removes licencing complexity for manufacturing in India
  • No import or export licence required for IMP in the free trade zone
  • No tax duty penalty for moving product into/out of the free trade zone
  • Secure, storage capacity for controlled drug
  • Local sourcing of Comparator and Clinical Ancillary Management supplies
  • Cold chain capability – dedicated pick & pack areas
  • Labeling design, translation and printing capability
  • Expertise in streamlining the supply chain
  • Full regulatory support strategy for Sponsors manufacturing in India & for import/export clinical supplies
  • Primary & secondary packaging tax efficiencies
  • Distribution & Logistics model to realize cost and performance efficiencies
  • Ability to withstand power outages due to back up generators
  • Certified returns & destruction service
  • Operational flexibility to facilitate all types of trials

Free Trade Zone (SEZ) & simplified regulatory packaging processes attract leading pharmaceutical company to India

Our client, a leading pharmaceutical company, focused its attention on India to conduct bioequivalence studies with clinical end points. The prevalence of disease indications and the ability to recruit patient numbers within an appropriate timeframe were two important factors of influence for the Sponsor. In addition, the increased pressure on today’s pharmaceutical companies to realize cost efficiencies prompted this Sponsor to conduct clinical trial studies in this region.

Realizing tax efficiencies While traditionally India had been considered as a difficult location from a logistics point of view, the strategic location of Fisher Clinical Services in one of India’s Free Trade Zones, also known as Special Economic Zones (SEZ), offered many advantages:

  • A duty free enclave, deemed to be a foreign territory for the purposes of trade operations, duties and tariffs
  • No import licence required
  • No import/export taxes applicable ( service tax, VAT, Excise & Custom Duty)
  • No routine examination by customs officials of import or export cargo

 

However, the Sponsor also needed to evaluate the breadth of services that could be provided by Fisher Clinical Services to facilitate clinical trial supplies in this region. To this end, the Sponsor and Fisher Clinical Services, India put a team together to discuss the Sponsor’s immediate and long term strategy for India.

Reduced inventory & shipment costs The team analyzed the Sponsor’s proposed distribution model and expected shipping requirements in order to deliver clinical trial materials On-Time and In-Full to investigator sites across the region. It was decided that the best route to market for this Sponsor was to have a Central Hub, from which all products could be dispatched at appropriate times to accommodate clinical trial timelines. This empowered the Sponsor to send bulk shipments of clinical supplies to this Hub, reducing inventory and shipping costs to the region. As many investigator sites were located in remote areas Fisher Clinical Services worked closely with the Sponsor’s team to validate the proposed logistics plan in advance.

Regulatory Support The strategic location of Fisher Clinical Services in the Free Trade Area, and the regulatory expertise of the local team, facilitated the import of clinical trial materials into India and, immediately resulted in time savings of up to 8 weeks for the Sponsor. In addition, the simplicity of regulatory processes for this Free Trade Zone in India allowed the team to finish a packaging project in advance of expected timelines for this Sponsor which brought forward the start date of its clinical trial.

Cold Chain Compliance The Sponsor was particularly keen to ensure that its temperature-sensitive clinical supplies would not be compromised in any way. It was important that its compounds would be maintained at their specified temperature during storage and transportation. The Fisher Clinical Services facility at Ahmedabad was chosen by the Sponsor due to its Good Manufacturing Practices, with redundant compressors and back-up power generators to ensure temperature compliance, whether ambient, refrigerated or frozen. In addition, all Fisher Clinical Services shipments were tracked and traced giving visibility of all supplies in motion and at rest.

Visibility Having total visibility of all supplies was of utmost importance to the Sponsor in order to ensure its Intellectual Property was maintained across the supply chain. To this end the Sponsor received customized monthly reports from the Global Logistics Helpdesk at Fisher Clinical Services demonstrating chain of custody across the supply chain.

New studies This leading pharmaceutical company continues to deploy clinical end point bioequivalence (BE) studies in India in partnership with the experts of choice – Fisher Clinical Services.

Phase II studies streamlined to accelerate delivery to patient

The globalization and changing regulations of clinical trials has led to the inclusion of many Asia Pacific countries in the portfolio of target countries for clinical trials today. For example, traditionally only clinical trial data from Japan was accepted by Japanese Authorities
(PMDA) for clinical trials for Japanese registration. Recently however, this regulation has changed. The PMDA now accepts clinical trial data from other Asian countries – Korea, Taiwan & China – in addition to Japan.

Phase II Studies
Our client, a Japanese pharmaceutical company chose to conduct its clinical trials outside Japan and selected India as the country of choice for the packaging of its Phase II trial. Fisher Clinical Services was the partner of choice for this Sponsor due to its Free Trade Zone location and its compliance with jGMP, Japanese standards, including 100% inspection. Having selected a new compound for clinical development, it was imperative for this Sponsor to streamline clinical trial deployment, maximize efficiencies and mitigate risk, with a view to accelerating time to market in this highly competitive environment.

Packaging Efficiencies
The Sponsor identified Fisher Clinical Services, Ahmedabad, as the only facility in Asia Pacific fully audited and approved by the MHRA for clinical trial packaging. Strategically located in a Free Trade Zone, the Sponsor was able to store its IMP at the Fisher Clinical Services Ahmedabad facility:

  • Before clinical trial approval
  • Without the need for an import license

 

Once official approval was granted to the Sponsor, the Fisher Clinical Services team was primed to initiate packaging immediately. Furthermore, smaller batch sizes were accommodated, whether automated or non-automated, allowing the Sponsor to speed up clinical supplies to the target patient base.

Operational Flexibility
It was important for the Sponsor to ensure Japanese standards were being upheld in Ahmedabad. Fisher Clinical Services resolved to find a creative solution to meet this Sponsor’s needs. By using “Virtual Man in Plant” Technology, the Sponsor could visit Fisher Clinical
Services in Japan, to view live packaging activities in Ahmedabad via a secure video link. This enabled the Sponsor to ensure standards were being maintained.

Tax savings
The Free Trade Zone, a duty free enclave, deemed to be a foreign territory for the purposes of trade operations, duties and tariffs offered additional benefits:

  • No license required for import/export
  • No direct or indirect taxation (service tax, VAT, Excise/ Custom Duty & import/export tax)
  • No routine examination by customs officials of export or import cargo

 

Global Distribution
The benefit of outsourcing to a global player was further evident to the Sponsor as the project progressed. The Sponsor was able to communicate with just one key contact person in Japan. The ability to work in the same time zone and the same language made it easy to conduct business with Fisher Clinical Services. This contact then managed all communication within the
extended Fisher Clinical Services network.

The distribution of supplies was seamless to the Sponsor. Fisher Clinical Services Ahmedabad worked with colleagues in Japan and Singapore to streamline distribution of supplies in small batch sizes. In addition, this key contact person in Japan had the regulatory expertise that was needed to facilitate importation of supplies back into Japan and into Singapore.

Fisher Clinical Services expertise in shipping large volumes of supplies globally, and in choosing the best courier, lane and route for all supplies allowed the Sponsor to realize cost and performance efficiencies across the supply chain, delivering supplies On-Time and In-Full to the patient, whilst mitigating risk.

This Japanese Sponsor is planning to follow this seamless, proven approach for future trials – packaging in India and distribution across the Fisher Clinical Services global network.

Global expertise and Free Trade Area location facilitates biosimilar studies

The biosimilar market is one of high growth potential for many large pharmaceutical companies, generic manufacturers, biotechnology companies and new market entrants worldwide.

The Indian biosimilar market has demonstrated robust growth over the past few years placing India in a position of leadership in the global market. The low cost manufacturing capability of India based companies is a definite attraction to pharmaceutical companies striving to achieve cost efficiencies. However, there are additional factors that can influence the decision to choose a global player to help conduct clinical trials in India.

Study Design
Our client, a leading Indian pharmaceutical company, approached Fisher Clinical Services, Ahmedabad, to support its clinical development program from the outset. As this was a complex study, a dedicated team was set up with representatives from the Indian Sponsor and from the Fisher Clinical Services team at Ahmedabad, to review all aspects of the Sponsor’s biosimilar study including:

  • study design
  • regulatory requirements
  • comparator sourcing strategy
  • blinding techniques
  • labeling
  • storage capacity, particularly cold chain
  • distribution and logistics

 

Comparator Sourcing
Comparator Sourcing was a key component of the Sponsor’s clinical development program. The Comparator Center of Excellence team at Fisher Clinical Services was best placed to assist the Sponsor in developing a sourcing strategy for innovator reference products for this trial. Defined processes to check for counterfeit products, and the application of stringent sourcing strategies assured the Sponsor of the authenticity of comparators sourced by Fisher Clinical Services.

Regulatory Compliance
One regulatory requirement in India is that IMP can only be imported into India once Clinical Trial approval has been granted. However, as Fisher Clinical Services, Ahmedabad is located in a Free Trade Zone, this is deemed as foreign territory, which facilitates the import of IMP into this zone for storage until the clinical trial has been approved. In this instance the Sponsor chose to store its IMP at Fisher Clinical Services, India so that it was ready for distribution immediately once clinical trial approval was granted.

Free Trade Zone

The strategic location of Fisher Clinical Services in a Free Trade Zone offered many advantages to the Sponsor:

  • Ability to bring comparator products to the Fisher Clinical Services Ahmedabad facility with ease, without the need for an import licence
  • No import/export taxes applicable to these comparator products

 

GMP Facilities
Fisher Clinical Services, Ahmedabad, is the only facility in Asia Pacific that is fully audited and approved by the MHRA for clinical trial packaging. In addition, patented blinding techniques assured the Sponsor that the clinical trial materials would not be compromised in any way across the supply chain. The Sponsor chose to work with Fisher Clinical Services due to its GMP compliant systems and processes – a real differentiator in the region.

Supply Chain Risk Mitigation

It was of utmost importance for the Sponsor to have full visibility of all clinical trial materials in motion and at rest across the supply chain. Furthermore, temperature sensitive supplies had to be maintained in cold chain conditions during storage and transportation to the investigator site. Fisher Clinical Services provided these services and delivered all supplies On-Time and In-Full,
achieving cost and performance efficiencies across a risk controlled supply chain to investigator sites.

The Sponsor and Fisher Clinical Services worked closely throughout the duration of this trial to ensure a smooth supply chain and, above all, patient safety at all times.