Business Models

“Driven by Expertise”

With high level operational flexibility, and an unparalleled client-oriented approach, we are in position to strategically interact with a diverse client portfolio to provide top-class drug safety services.

Whether it is a customized service for a small pharma or a full PV package allocation for a market leader, our goal remains unchanged:

Continuous, effective and qualitative surveillance of the safety profile of your products to ensure peace of mind with regulatory compliance and uneventful market presence, regardless of your operating business model and capacity. We have invested heavily in IT systems to work with cutting edge technologies in order to minimize unnecessary workload and optimize our procedures.

All safety and regulatory systems are installed in-house at Pharmathen’s data center.

Our continuing expansion in terms of operations, technology, projects, market penetration and clientele is our unambiguous credential: “We have become exceedingly efficient at meeting our goal”!

Our Pharmacovigilance system is fully aligned with ICH and other international standards, running on an ISO 9001:2008 certified QMS, and has repetitively been audited successfully by National Health Authorities and major stakeholders in the pharma industry over the last years.

Timely creation of 60 PSURs within 2 months on behalf of one of our major clients for urgent submission to their local Authority.

No safety data from the medical literature were available, so full retrospective screening of a broad time period along with review and classification of results was also necessary.

Relief of significant backlog ICSR volume for an affiliate identified during an Authority Inspection. By employing smart project design, sophisticated in-house multilevel deduplication techniques, critical quality review of clean output and efficient data handling for the transfer later on, we completed the project in 50% of the overall time requested by the Inspector.

Combining seemingly unrelated data from our databases to identify the use of a well-established molecule for the off-label treatment of perinatal asphyxia, an orphan disease that lacked effective pharmaceutical treatment. We have filed the relevant dossier and managed to obtain an orphan drug designation shortly after.

Submission of two prime quality service delivery proposals to the EMA for the screening of medical literature for case reports and processing of the same, and for the Eudravigilance data cleanup and management. Both proposals ranked exceptionally high (in top three).

PSUR writing retrospective literature

Timely creation of 60 PSURs within 2 months on behalf of one of our major clients for urgent submission to their local Authority. No safety data from the medical literature were available, so full retrospective screening of a broad time period along with review and classification of results was also necessary.

Case Reports

Relief of significant backlog ICSR volume for an affiliate identified during an Authority Inspection. By employing smart project design, sophisticated in-house multilevel deduplication techniques, critical quality review of clean output and efficient data handling for the transfer later on, we completed the project in 50% of the overall time requested by the Inspector.

Drug repurposing

Combining seemingly unrelated data from our databases to identify the use of a well-established molecule for the off-label treatment of perinatal asphyxia, an orphan disease that lacked effective pharmaceutical treatment. We have filed the relevant dossier and managed to obtain an orphan Drug designation shortly after.

Literature strategy, data management, proposal writing

Submission of two prime quality service delivery proposals to the EMA for the screening of medical literature for case reports and processing of the same, and for the Eudravigilance data cleanup and management. Both proposals ranked exceptionally high (in top three).

A synopsis of our operations

We offer a full range of core pharmacovigilance services customized to your needs, providing end-to-end coverage for your product portfolio. Either be it from writing or reviewing your SOPs, to supporting you during an inspection or running a mock audit for you, to training and consultancy, we can fully cover you to achieve compliance and increase productivity. We offer a wide range of signal detection services including classical ad hoc clinical evaluation of case reports and/or statistical analysis to detect abnormal reporting frequency fluctuations throughout vast datasets of case reports. We can also undertake Emergency Communications and trigger Risk Escalation / resolution processes. We can act as your local PV liaison with Authorities in all EU regions or even assume the EU QPPV responsibility for your products. Our Local PV Services include: Local contact person availability and back-up system, local legislation monitoring, local non-indexed literature screening, case collection & follow-up, NCA inspection readiness/support.

Our patent department is well-known in the industry for providing excellent patent reports for the projects that we out-license to our customers. We also engage top class scientific advisors and we can provide experimental reports in order to back up our positions. We also file and prosecute globally an extensive number of patents. All this work, searching, analysis, drafting, patent prosecution is performed by our internal patent team We can offer the following IP services:

Freedom to operate reports

Comprehensive reviews of all patents (including status checks) relevant to the INN. These can also be tailored to your needs, i.e synthesis, intermediates, formulation, physical chemistry, use claims etc. The reports can be provided alone or with a review of your product.

Patent drafting

We offer a full range of services that includes drafting, filing, prosecution and renewal, in any life science field.

Strategy

We recognize that although any external patent attorney can offer analysis of a patent claim, they may not be able to offer solutions. Which is why we always deliver products that combine the best in commercial viability, timing and low business risk.

Our Services

Our team can provide assistance with the following:

System Development & Standalone Services

Our safety surveillance portfolio comprises thousands of medicinal products stemming from the worldwide monitoring of around 200 active substances of own and client’s medicinal products. We currently assume full pharmacovigilance services for dozens of third parties, maintain XEVMPD datasets for thousands of medicinal products and have implemented hundreds of safety agreements actively implicating Pharmathen on a global PV network. We have invested heavily in IT systems to work with cutting edge technologies in order to minimize unnecessary workload and optimize our procedures. All safety and regulatory systems are installed in-house at our data centers. In addition, our group of experts is acting as the nominated Local Pharmacovigilance Contact for a number of top multinational pharmaceutical companies.

PV System: we offer a full range of core pharmacovigilance services customized to your needs, providing end-to-end coverage for your product portfolio.

QMS:either be it from writing or reviewing your SOPs, to supporting you during an inspection or running a mock audit for you, to training and consultancy, we can fully cover you to achieve compliance and increase productivity.

Risk monitoring & management: we offer a wide range of signal detection services including classical ad hoc clinical evaluation of case reports and/or statistical analysis to detect abnormal reporting frequency fluctuations throughout vast datasets of case reports. We can also undertake Emergency Communications and trigger Riskescalation / resolution processes.

Local PV Network & EU QPPV: we can act as your local PV liaison with Authorities in all EU regions or even assume the EU QPPV responsibility for your products. Our Local PV Services include: Local contact person availability and back-up system, local legislation monitoring, local non-indexed literature screening, case collection & follow-up, NCA inspection readiness/support.

Operations & Technical Competency

Case Management: we host on our premises an E2B compliant fully validated database with gateway transactions for end-to-end processing of case reports. Alternatively, we can conduct case management remotely connecting to your technical resources or using EVWeb.

IT Infrastructure & Tools: we can help you with xml data analysis, transformation, migration and uploading onto structurally E2B- compliant databases.

XEVMPD: We can insert and maintain your Article 57 data for your medicinal products either via EVWeb or from a gateway solution.

Literature Monitoring: we can relieve you from the burden of routine and/or retrospective literature screening and deliver quality records for your compliance.

Aggregate Reports: we can deliver high quality reports for your products in line with legislative requirements and client needs.

Medical Writing & Consultancy Operations

Medical Writing: we produce high quality scientific documentation throughout the lifecycle of a medicinal product at all regulatory phases (Clinical or Non-clinical Overview, compilation and implementation of RMPs, PI-CCSI, readability test support etc).

Med Info Queries: we can file, triage, respond and reconcile medical enquiries related to your product.

Business Intelligence, Drug repurposing: we employ combined resources to achieve strategic consultancy and business development support on decision making based on the safety profiles of the products. We combine Pharmacovigilance, Pharmacoepidemiology and Pharmacogenetics to critically reevaluate data in order to achieve protection of public health, assure corporate regulatory compliance, improve current therapies and address unmet medical needs.

Safety Monitoring of Clinical Trials, Cosmetovigilance, Materiovigilance: Our range of services is extended to include review of clinical and non-clinical study protocols, investigator brochures, and final study reports with end-to-end analysis of safety-related data from clinical trials and post authorization studies; post-hoc scientific and statistical analysis of safety data; preparation and application for the WHO Prequalification Program; complete implementation of a Cosmetovigilance / Materiovigilance system; and more.

Upcoming challenges for the industry can be effectively supported by Pharmathen: - New EudraVigilance system, E2B (R3)
- EVDAS compliance
- New MDR
- IDMP

Our ATC portfolio: Ophthalmics
Pituitary & hypothalamic hormones, antiparathyroid agents
Respiratory drugs
Statins and fibric acid agents
Topical antifungals and corticosteroids
Urologicals
Vitamins and minerals
Drugs for alimentary disorders
Antibiotics, antimycotics and antivirals
Antidiabetics
Antineoplastics
Antiinflammatory and topical pain killers
Antithrombotics
Bisphosphonates
Cardiovascular drugs
CNS drugs

“cGMP Quality Control (QC) testing for excipients, intermediates, raw materials, APIs and GMP batch release testing for drug products supporting pharmaceutical development and manufacturing”

We provide GMP quality control analysis and offers technical advice on the most cost effective approaches to QC testing for GMP manufacture of pharmaceuticals.

Quality control analysis, GMP microbiology release testing and GMP batch release testing is a routine activity in our network of GMP analytical laboratories which have a lot of experience for drug products.

We provide a full range of pharmacopoeial testing. If existing pharmacopoeial (compendial) methods are not appropriate, Pharmathen can provide method transfer for our client’s methods covering a wide analytical technology scope from HPLC, GC, FTIR, and more. Expertise includes solids, semi-solids, lyophilized powders, liquids, parenterals etc.

-Compendial analysis for Excipients and Raw Materials Analysis (USP, EP and JP)
-Client specific method
-Intermediates & Finished Product Testing
-GMP batch Release Testing
-ICH Stability Testing & Storage
-Microbiological quality of sterile and non-sterile products

“More than 20 years of experience in regulatory submissions worldwide”

With our extensive experience in Regulatory Affairs and strong scientific background, we understand and can interpret regulatory scenarios for our clients and we can provide a wide range of approval strategies as well as the most advantageous authorization routes to ensure a product reaches the market fast and efficiently.

Strategic & Product Planning

Our primary focus is to use our expertise to ensure we globally provide high quality regulatory affairs advice, from the early concept stage and strategy building, up to and beyond dossier submission and marketing authorization ensuring that your products are not only marketed by the quickest and most cost effective route, but remain on the market.

Synopsis

Strategic and product planning
Regulatory submission
Lifecycle management
Regulatory support

Some of Our Services Include:

-Regulatory project management and a wide range of approval strategies to ensure a product reaches the market fast and efficiently
-Continuous Regulatory support and guidance, with well-defined clear objectives and appropriate milestone allocation
-Regulatory Intelligence
-Regulatory Documentation and full medical writing activities (Quality, Clinical, generating SmPCs/PILs, Labelling)
-High profile meetings with Authorities and thorough Agency interactions, liaising with an established network of Agency contacts Regulatory Sub

We can provide assistance with the following:

-High quality CTD / e CTD compliant dossier preparation to ensure efficient review by the Regulator (for all countries requiring an eCTD submission including EU, GCC and KSA countries, South Africa etc)
-Extedo eCTD Manager Software – ICH compliant
-Review of raw data and reports for inclusion in the regulatory submission
-Worldwide Marketing Authorisation applications (including National, MRP, DCP, CP)
-Review of Authority Assessment Reports and preparation of quality responses with the appropriate level of detail
-Preparation of clinical and non-clinical overviews, and full scientific support
-Interaction with Authorities to establish crucial quality, clinical and non-clinical plans of action (Scientific Advice)
-Preparation and evaluation of toxicological reports
-Genotoxicity evaluation
-Preparation of product information texts including user tested patient leaflets
-WHO Prequalification of Medicines Programme
-EMA Article 58 procedure

Life cycle management

“We always in the lead in assessing the risk-benefit profile of each medicinal product, guaranteeing you safety of medicinal products at all times”

Our Regulatory team appreciates that a Marketing Authorization requires continuous monitoring and provides continuous support to the client, by developing strategies for post approval activity. -Organization and coordination of post approval activity (PSURs, Type IA/IB/II Variations including Grouping and Work-sharing, Renewals, commitments) and all associated strategies -Preparation and submission of supporting data -Proactive approach in reviewing data and organizing appropriate meetings with regulators to address future issues

Regulatory Support

Our Regulatory Affairs department extends its services to excellent due diligence assessment when a client considers licensing in a novel product for which in-house expertise may not be available to assess the regulatory implications of the product. With our accumulated experience we can help clients evaluate business opportunities, and provide reassurance on the superiority of the dossier and minimize the risk of unsuccessful investments.

Our due diligence services include:

-Assessment of product development strategies, evaluation of possible regulatory obstacles and perspectives for marketing authorization
-Business opportunities for novel pharmaceutical products
-Feasibility studies to assess regulatory implications of alternative production processes

CRO selection

“A successful preclinical and clinical development program is always a challenge in the pharmaceutical world”

Having great experience with many CROs worldwide—as well as in Clinical Trial Application processes and timelines of the regulatory environment in many counties around the world—we can guide you through the process of prequalification site-audit, in order to select the CRO that’s ideally suited to your clinical development.

After an initial screening of many CROs, we contact all key persons and collect all the information required for our evaluation. This process allows us to focus better on the option that’s ideal for a particular client. The final selection includes additional parameters, such as pre-qualification audits, scientific background of personnel involved, available expertise, current regulatory environment, consistency, cost savings, general response time, timelines, lead-time, regulatory approval time, prior experience, etc.

Monitoring Services

Our expertly-trained clinical associates ensure the highest quality of study monitoring in all phases of Bioequivalence studies or clinical trials. More specifically, on-site monitoring visits throughout the study are conducted in order to:

-Oversee data collection
-Review source documentation and case report forms
-Ensure regulatory compliance
-Resolve data queries
-Conduct interim analyses
-Harmonize and ensure the high quality

Preclinical and Clinical design and medical writing

Our highly-qualified medical writing team consists of experienced MSc and PhD-level scientists, and can assist you on every development stage:

-Preclinical and Clinical study design
-Protocol writing
-Clinical reports
-Investigators brochure
-IMPD and compilation of clinical trial application documents
-Design and Compilation of Pediatric Investigational plans

In Vivo - In Vitro Correlation (IVIVC)

The development and validation of an IVIVC model is an important component of dosage form development and optimization.
An IVIVC model is a relationship (preferable linear) between a biological parameter (i.e., Cmax, Tmax or AUC) produced by a dosage form and an in vitro characteristic (i.e., in vitro dissolution).

The development of the correlation usually involves the following three steps:

01 Develop formulations with different release rates
02 Obtain in vitro dissolution profiles by a suitable dissolution test and in vivo plasma concentration profiles
03 Estimate the in vivo absorption curve using appropriate deconvolution techniques (e.g., Wagner-Nelson model, numerical techniques).

There are four IVIVC categories including Level A, Level B, Level C and multiple Level C

The highest level correlation, Level A, is a direct point-to-point relationship between the amount of the drug dissolved (in vitro data) and the amount of the drug absorbed (in vivo data). In other words, a Level A IVIVC model should predict the entire in vivo time course from the in vitro data. In a Level B IVIVC, the mean in vitro dissolution time is compared either to the mean residence time or to the mean in vivo dissolution time.

A Level C IVIVC establishes a single point relationship between a dissolution parameter (e.g., percent dissolved at a specific time point) and a pharmacokinetic parameter (e.g., Cmax, Tmax, AUC) while a multiple Level C IVIVC correlates one of several pharmacokinetic parameters of interest to the amount of drug dissolved at several time points of the dissolution profile.

We develop and apply IVIVC models using the following software packages

-Microsoft Excel
-MATLAB
-Winnonlin

The application area concerns:

-Optimization of the product development procedure (e.g., highly demanding products, sustained release formulations)
-Optimization of the pivotal BE studies designs (i.e., repeated dose studies)
-Support post-approval changes (i.e., modifications affecting dissolution rates)

“Commitment in dependability and reliability”

Third party audit (TPA) - GMP services

Pharmathen offers professional services of conducting GMP audits, in particular APIs, to support Marketing authorization / Manufacturing license holders to comply with Article 46f of the Directive 2001/83/EC & 2001/82/EC and “the rules governing Medicinal Products in the European Union, Volume 4 Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Part II (formerly Annex-18), Basic requirements for Active Substances Used as Starting materials”

The audit program of TPA services is in line with EU directives (Article 46f of 2001/83/EC) of API GMP expectations, commission delegated regulation (EU) No 1252/2014 of supplementing Directive 2001/83/EC & as per European Medicine Agency (EMA) guidance on the use of GMP compliant APIs manufactured in GMP compliant sites verified by the MA holder; EMA/196292/2014, 21 May 2014, Guidance for the template for the qualified person’s declaration concerning GMP compliance of active substance manufacture (the QP declaration template); European Medicines Agency (EMA) directive dated 21 May 2014 of MA/334808/2014, Qualified Person’s declaration concerning GMP compliance of the active substance manufacture “The QP declaration template” & EudraLex The Rules Governing Medicinal Products in the European Union Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part 1 Chapter 5: Production : Starting Materials # 5.27 & 5.29.

Our TPA services help the applicant of a marketing authorization or a manufacturing authorization holder to issue a declaration that the active substance(s) concerned has/have been manufactured in accordance with above directives.

Our TPA services are in line with the EMA (European Medicine Agency) GMP inspection group’s aspirations, meaning that the results of an audit conducted by the third party are credible thus waiving the need for an audit conducted by the manufacturing authorization holder itself.

Brief synopsis on Pharmathen’s TPA services - Auditing Program – Report Structure Audit Report Format consisting of following key levels & types*

By this concept, each product details (narration as well as product specific observations) shall be kept separately as stand-alone such that any customer who is interested in a particular product shall be delivered 2-sets, i.e. 1 with systems specific and 1-product specific, and therefore the integrity of each product information is protected and it is not disclosed. This is giving consideration to the multiple products and different customers encountered and hence not to give unnecessary irrelevant extra info etc.

The audit program is a comprehensive service beginning with the “pre-audit” evaluation, followed by the actual conduction of the audit and detailed reporting, until the follow-up of formal audit observation closure/s. It also involves re-audit(s) or compliance audit(s) as and when required and as per the frequency and requirements of our clients.

Our experienced International Audit team is highly qualified and experienced in conducting Audits and reporting, having already conducted more than 1000 audits covering not only APIs, but also extending into finished dosage forms, packaging and laboratory operations, sterile products and starting materials like KSM, advanced intermediates chemicals etc.

These audits so far have been conducted all across Asia, EU and the US. You can feel assured of the services offered as they are based on our fundamental principle, “Commitment in dependability and reliability”. Please find attached a short presentation that gives a more detailed description and the overview of our services.

Auditing Program – Report Structure. Audit Report Format consisting of following key levels & types*

01 – Audit Report – ‘AR’ Main section with 9 attachments
02 – Attachments (AT-1 to AT-9) on each section described individually, with ‘AT-1 to AT-8’ being systems specific, AT-9 is product specific, AT-10 only for sterile specific
03 – Audit Report Cross Reference file (pre-audit preparation data) – ‘ARC’
04 – Audit Report Supporting Data release checklist (post-audit annexure data) – ‘ARS’
05 – Audit Report release checklist (formal release) – ‘ARR’
06 – Annexure in support of report – additional stand-alone files as listed out in ‘ARS’ and ‘ARR’ with previous audit reference

Synopsis

-International Audit Team placed strategically in India.
-In-line with the EMEA GMP inspection group’s aspirations on 3rd party audits.
-Expanding horizons to meet global demands.
-Committed to be dependable & reliable with trustworthiness to partners.

Track Record

-International Audit Team placed strategically in India.
-In-line with the EMEA GMP inspection group’s aspirations on 3rd party audits.
-Expanding horizons to meet global demands.
-Committed to be dependable & reliable with trustworthiness to partners.

History

-Established in December 2007 to offer service to industry.
-Continued relationship with several clients since establishment.
-Signed exclusive arrangement with leading Generics.
-Companies globally.
-Existing clients from EU, US and Canada comprising of leading Global Generic pharmaceutical companies.
-Client requests include new enquiries & repeat interests.