• Symogen
    Global Experts in Pharmacovigilance - Service Providers & Outsourcing
  • Pharmacovigilance
    Pharmacoepidemiology - Medical Writing - Regulatory Services.
  • Global Presence
    With Offices in the United Kingdom, United States and India

Experts in Pharmacovigilance...



Symogen is a niche service provider for all aspects of Pharmacovigilance, Pharmacoepidemiology, Medical Writing & Regulatory Services.

Established in 2007, our clients are large and midsize pharmaceutical and biotech companies.

Symogen has an impeccable reputation for excellent customer services and extremely ethical
and high quality of work under the leadership of Dr Pipasha Biswas.



Mission



Symogen believes in working together with our clients in an ethical and transparent manner to advance the science of proactive pharmacovigilance
to meet the regulatory demands. We give quality service to our clients, based on continuous innovation, high quality and total confidentiality.



Experience

More than 18 years of experience providing Pharmacovigilance and Pharmacoepidemiology services, our of global experts include highly qualified, trained and experienced professionals from the corporate and academic world.

Quality

By understanding and improving operational processes; identifying customer requirements quickly and systematically; establishing valid and reliable service performance measures and measuring customer satisfaction.

Innovation

Research and innovation is an important part of Symogen business development process. We focus in several research projects to continually improve and enhance the quality of our services and to meet the high requirements of our customers.

Our Team


Symogen staff in Pharmacovigilance and Pharmacoepidemiology are experts, who include highly qualified, trained and experienced professionals
who have many years of experience in pharmaceutical companies and from academia in Europe, USA and India.



Dr Arun Kumar Biswas
Managing Director
and Chief Medical Officer

+ More Info
Dr Pipasha Biswas
Executive Director & QPPV
+ More Info
Bobby Mahajan
Director & Head of Global Pharmacovigilance operations
Howard Abroms
Director Global Business Development
+1 203 274 0016 Cell
+1 424 247 7035 Office
howard@abromsmay.com

Pedro Berrio
IT Director
+ More Info
Dr. Susan Bews
Dr. Lynda Wilton
  • "Excellent knowledge in pharmacovigilance especially in Signal Detection and Risk Management. Approachable and executes work meticulously, accurately and on time”Senior Safety Science Leader, Roche Pharma
  • "Deep understanding of safety risk management; is a real asset to companies needing pharmacovigilance support."President & CMO, Glenmark Pharmaceuticals
  • "Professionals with an abundance of pharmacovigilance experience used to produce quality work in a timely fashion. Symogen values success of the team and is genereous in sharing their experience, knowledge and time."Director, International PV, Eisai
  • Expert knowledge of PV, enthusiasm, leadership & excellent skills."Senior Pharmacovigilance Manager, Astellas Pharma

Our Services

ADR Case Processing , Reporting & Submissions 24/7/365: Drugs, Vaccines, Medical Device, Cosmetics & Nutritionals


  • Book in, Triaging & 24/7/365 Case Management Support
  • Data entry into validated electronic PV database
  • 100% Quality control of all ICSR including medical QC
  • Medical review and assessment, narrative writing, MedDRA coding
  • Product Quality Complaints Management
  • Reporting & Submissions: Electronic (E2B), Hard copy (CIOMS, MedWatch 3500A drug, etc.) to worldwide regulatory authorities


Literature Review, Search & Monitoring


  • Full text weekly searches from worldwide literatures
  • Ongoing, weekly literature monitoring for identification of ICSRs (Individual Case Safety Reports)
  • Active ingredient specific - alternative names/ Product specific search
  • Integration with case processing in safety database
  • Full text articles procurement and translation


Production, Generation & Submission of Aggregate Reports (PBRERs, PADERs, SBRs, ASRs & DSURs)


  • Production of Product Specific Line Listings
  • Complete authoring and production of PEBRERs, PADERs, SBRs, DSURs/Addendums/SBRs/Addendum to clinical Overview
  • Compliant Formats: ICH E2C, GVP Modules; US FDA CFR Part 314.80

Safety Data Exchange Agreement Management


  • Authoring and preparation of SDEAs customized per global regulatory requirements
  • Review of SDEAs
  • Negotiating safety aspects to be included in the SDEAs with business partners


Provision and Support with EU-QPPV & DQPPV


  • 24/7/365 Support with EU QPPV & DQPPV Good PV Practice Modules (GVP) - New EU PV Regulations
  • Oversight of the PV System in terms of structure & performance to ensure appropriate collation of ADRs, preparation and sign off of regulatory documents (PSURs etc) and Post-Authorisation Safety Studies (PASS Studies)
  • Ensuring all requests from Regulatory Authorities are answered completely and promptly

Quality Assurrance (QA) Services: Audits; Inspections GVP and GCP


  • Review & manage Compliance metrics for ADR reporting to regulatory authorities
  • Undertake Mock PV Audits for QPPV Office & Global PV depts.
  • Undertake GCP Audits
  • Develop & Implement Quality Management System (QMS)
  • Support & Prepare for Inspection readiness & business partner and external audits
  • Gap Analysis of systems & processes
  • Identify and Prioritize improvements & CAPA support for closure of inspection findings


Signal Detection- Benefit Risk Evaluation


  • Support with Identification and Prioritization of Signals from company databases
  • Complete work up of signals including, signal evaluation, epidemiological input and closing of signals
  • Authoring of Signal Evaluation Reports (SERs) or Issue Work Ups of signal for regulatory submission
  • Communication of Signals to Regulatory Authorities and Prescribers
  • Authoring of Dear Doctor & HCP Letters


Risk Management Plans/ REMS


  • Authoring and preparation of EU RMPs and REMS
  • Help & Support with preparation of Medication Guides, Educational Materials and other Risk Minimisation Plans
  • Help & Support with Survey and testing as a measure of effectiveness of RMP/REMS with patients and prescribers


Labelling: IB; SmPC, PIL, CCDS & USPI


  • Preparation and authoring of labelling documents and Reference Safety Information for products (CCDS, SmPCs, IBs, PILs)


Education & Training in Pharmacovigilance


  • Pharmacovigilance specific trainings for PV/Safety departments
  • Comprehensive Interactive e-Learning Certificate Course in Pharmacovigilance & Pharmacoepidemiology


Pharmacoepidemiology Services


  • Epidemiological Literature Searches & Reviews
  • Support with Study Design & protocols for studies
  • Support with PASS Studies
  • Authoring of Pharmacoepidemiological Study Reports
  • Post– Approval Safety Studies (PASS)


Medical Writing Services


  • ICSR Narratives—Company Assessment & Comments
  • Causality Assessments
  • Risk Benefit Assessments
  • Analysis of Similar Events
  • Integrated Safety Summary (ISS)
  • NDA Clinical Report Safety Sections
  • Patient Profiles in Clinical Trials Study Reports
  • Preparation of Clinical Overview & Clinical Summary
  • Safety Signal Evaluation Reports
  • Preparation of PBRERs, PADER, DSUR, SBR
  • Preparation , authoring & maintenance of PSMF
  • Risk Management Plans (EU RMPs, REMS, PIPs)
  • Phamacovigilance Plans
  • Reference Safety Information (CCDS; SmPc, PI, IBs)
  • Dear Doctor & HCP Letters


Clinical Data Management Services


  • MedDRA Coding and Data Analysis
  • Reconciliation of Clinical & Safety Databases
  • Migration of Data and Legacy data from various databases
  • Generation of CIOMS Line Listings
  • Aggregate Reports: PBRERs, PADERs, DSURst
  • Analysis of data for signal detection
  • Data Mining from various databases


Clinical Drug Development Services


  • Clinical Trial Safety Support - Phase I, IIa, IIb & III
  • Preparation of Medical Management Plan
  • Preparation of Safety Management Plan
  • Preparation of Safety sections of eCTD for NDA, IND & BLA sub- missions
  • NDA, IND and BLA Safety Review
  • Authoring of ISS and Clinical Study Reports (CSRs)
  • Compassionate Use Programs Support & Monitoring


Regulatory Strategy Help & Support


  • xEVMPD Support for maintaining products on EV Database
  • Preparation /Review/Compilation of IMPD, BLAs
  • Preparation of CTD Modules 1.8.1 (PSMF) & 1.8.2 (RMP)
  • Regulatory Strategy Support in Early Development, Ph. IIb—III, Post-Marketing & Lifecycle Regulatory Support
  • Preparation of eCTD regulatory dossiers


Regulatory


  • Book in, Triaging & 24/7/365 Case Management Support
  • Data entry into validated electronic PV database
  • 100% Quality control of all ICSR including medical QC
  • Medical review and assessment, narrative writing, MedDRA coding
  • Product Quality Complaints Management
  • Reporting & Submissions: Electronic (E2B), Hard copy (CIOMS, MedWatch 3500A drug, etc.) to worldwide regulatory authorities

Case Studies



Strategic Advice and set up of Pharmacovigilance:
A leading Generics Company with R&D capability with several drugs in clinical development pipeline requested Symogen Limited to help set up and strategise Pharmacovigilance in Europe and globally. Symogen Limited has helped the company in advising on Global PV database set up including systems and processes, CTs safety support, prepare Safety management Plans for drugs in development, set up of and advise on Prescription Event Monitoring (PEM) Studies for drugs in India with KOLs; audit and inspections of all their affiliate offices globally; set up of PSUR processes and systems and authoring; developing and preparing CCDS from scratch and help prepare Safety Data Exchange Agreements (SDEAs).
Global NDA Submission for Oncology Product:
A MNC requested Symogen Limited to help in the entire PV management and work for global NDA submission of novel Oncology product to FDA, EMA and PMDA. Symogen Limited managed the entire project including assessment, analysis of various data from several Phase II and III clinical trials, DSMB data review, assessment and responding to DSMB, reviewing and authoring of several important documents including Integrated Safety Summary (ISS); Clinical Study Reports; Patient narratives and safety narratives, DDPS etc. Symogen Limited also prepared from scratch the Risk Management Plans, EU SmPC, US PI and other safety documents for eCTD submissions globally. This project was completed by Symogen Limited in 12 months time and well before global submissions that enabled the sponsor company to submit MAA to all the three regulatory agencies FDA, EMA and PMDA before the actual date of submission.
Good PSUR Practice and Quality Review of PSURs:
A MNC requested Symogen Limited to help them with setting up and strategise a Good PSUR Practice process, as they had received several assessment reports from various regulatory agencies regarding the low quality standard of its PSUR which was one of the triggers for an inspection. Symogen Limited helped the company by spending over four weeks in understanding the current set up and then entirely changed the process and gave training in writing a PSUR including understanding the content and developing a new PSUR template as per EU regulations. Symogen Limited also helped the sponsor company to set up a pilot project for the PSURs and in strategising which PSUR should be done in house and which outsourced. With the implementation of this new process and setting up of the Good PSUR Practice, regulatory authorities have sent positive feedback and assessment reports to the sponsor.
Signal Detection and Issue Work Up:
A MNC requested Symogen Limited for urgent help to review and close over more than 7000 PT terms each of the Signals for their Transplant and Oncology portfolio group of drugs. This project included detailed analysis of the events and Issue Work Up of these signals identified through Quantitative Signal Detection and Management Tool and then authoring of several Safety Reports for the signals that were generated for submission to the Regulatory Authorities. This project helped the sponsors to get on top of the signals for these therapeutic areas and close all the signals.
Urgent Safety Issue requiring DHCP Letter:
A MNC requested Symogen Limited to help with an Urgent Analysis and Comprehensive report authoring of a Specific Urgent Safety Issue that had to be submitted to EMA as part of CHMP request. Symogen Limited executed the project by doing a detailed analysis of all the events involved for this specific issue, wrote the entire report consisting of more than 200 pages and also authored the Dear HCP letter for submission to the Regulatory Authority.
Pre-inspection Assessment of Pharmacovigilance Systems:
A MNC requested a comprehensive assessment of both the pre and post marketing activities in its European headquarters and UK and Irish affiliates, and also requested help and expert advice in the preparation of upcoming MHRA Inspection. Contacted Symogen Limited for under taking Mock Inspection, as PV experts for QPPV Inspection, Inspection for Global Central Operations and Affiliate Pharmacovigilance Inspection. The assessment was conducted over a three-week period by an experienced pharmacovigilance expert and QPPV. The experienced pharmacovigilance expert ensured that the assessment identified key gaps in pharmacovigilance systems, and that pragmatic and effective recommendations for improvements were made. The company received the assessment report very positively and implemented corrective actions before the inspection. For those corrective actions that required a longer implementation period, a plan of action was prepared which was acceptable to the regulatory inspectors. As a result of the assessment, pharmacovigilance personnel were well prepared for the subsequent inspection, which progressed smoothly with very few findings
  • Case Study 7
  • Case Study 8
  • Case Study 9
  • Case Study 10
MHRA PV Inspections:
A MNC requested Symogen Limited for help with their forthcoming MHRA Inspections in PV after receiving several critical findings in previous inspections from various competent authorities. Symogen Limited helped them by changing and implementing several processes and handled the inspections professionally which resulted in positive comments by the inspectors and less significant findings.
Development and Preparation of SDEAs:
A MNC requested Symogen Limited for help with developing and preparing of several SDEAs for various products as part of the commitment following several inspections. Symogen Limited helped the company in preparing these legal documents interacting with pharmacovigilance department, legal department and various other license partners.
QPPV and Head of Drug Safety Pharmacovigilance Support:
A MNC requested Symogen Limited for help with QPPV and Head of Drug Safety & Pharmacovigilance support. Symogen Limited has helped the company with re-organisation and in providing strategic input for changing the PV department; liaison with all affiliates in setting up the systems and processes with global centres and making the company inspection ready for major inspections.
Development Safety Update Reports:
S ymogen Limited was appraoched to author several DSURs for products in development. The project was completed with experienced PV physicians and scientists who authored the DSURs for submissions to the regulatory agencies.

News

  • 14 June

    DIA 2015 June 14-18, 51st Annual Meeting gathering in Washington, DC

    Symogen will be at the DIA 2015 June 14-18, 51st Annual Meeting gathering in Washington, DC. Stop by our booth to forge new partnerships!

    If you wish to set up a meeting with us during the event contact us at Info@symogenlimited.com.

    The DIA Annual Meeting provides the best opportunity to meet with people from around the world, share your views and knowledge, network, and build new relationships with 7,000+ life sciences professionals.

  • 14 June

    51st DIA2015 @ConventionsDC, Washington DC, June 14-18

    Symogen will be at 51st DIA2015 @ConventionsDC in Washington, DC June 14-18. Stop by our booth 1856 to forge new partnerships!

    If you wish to set up a meeting with us during the event contact us at Info@symogenlimited.com.

    The DIA Annual Meeting provides the best opportunity to meet with people from around the world, share your views and knowledge, network, and build new relationships with 7,000+ life sciences professionals.

  • 22 APR

    World Drug Safety Congress America 2015, 22-23 April, Chicago, USA

    Dr. Pipasha Biswas, Executive Director and QPPV, SYMOGEN Limited speaking on From Signal management to Product Labelling at World Drug Safety Congress 2015 at Chicago.

  • 22 APR

    World Drug Safety Congress America 2015, 22-23 April, Chicago, USA

    Lucky draw winner Dr. Mariette Boerstoel, Head Global Drug Safety and Pharmacovigilance Baxter, receiving the bottle of Moët & Chandon Rosé Impérial Champagne from Dr. Pipasha Biswas, Executive Director and QPPV, SYMOGEN Limited at World Drug Safety Congress 2015 at Chicago.

  • 22 APR

    World Drug Safety Congress America 2015, 22-23 April, Chicago, USA

    Symogen team with Dr. Charles Dharmani, director of Pharmacoepidemiology & Risk Management at Astellas.

  • 27 APR

    World Drug Safety Congress America 2015, 22-23 April, Chicago, USA

    Symogen team with Dr. Michael Levine, Senior BSL at Novartis.

  • 11 May

    4th Pharmacovigilance, Drug Safety & Risk Management Conference, 11-12 May 2015

    Dr. Pipasha Biswas Executive Director & QPPV will be Chairing and speaking on "Cause & Effect - Striving Towards Proactive Surveillance Through Innovation" at the 4th Pharmacovigilance, Drug Safety & Risk Management Conference 11-12 May 2015 at Holiday Inn Regents Park Hotel, London.
    We look forward to meeting all the delegates.

  • 15 APR

    DIA – 27TH ANNUAL EUROMEETING PARIS 2015 | PARIS, FRANCE PALAIS DES CONGRÈS

    Thanks for visiting SYMOGEN booth at the 27TH ANNUAL EUROMEETING in Paris.
    It has been a great experience!!

  • 13 APR

    DIA – 27TH ANNUAL EUROMEETING PARIS 2015 | PARIS, FRANCE PALAIS DES CONGRÈS

    SYMOGEN will have a stand at the Drug Information Association (DIA) Annual EuroMeeting, April 13-15, 2015, Palais des congres, Paris, France.
    Visit us at our booth 3. D13 and meet our Team

    If you wish to set up a meeting with us during the event contact us at Info@symogenlimited.com

    The DIA’s Annual EuroMeeting is global in scope and attracts well over 3,000 professionals from more than 50 countries.

    For the first time ever, the EuroMeeting will be organised in parallel with the Clinical Forum. This will afford delegates unparalleled opportunities to interact and network with qualified professionals from throughout Europe and the world, and to meet a wealth of exhibiting companies, all under one roof. You will meet professionals from the pharmaceutical and biotech industries, CROs, clinical trial sites, health regulatory agencies and delegates from academia and patient organisations, and more.
  • 22 APR

    World Drug Safety Congress America 2015, 22-23 April, Chicago, USA

    SYMOGEN will be Bronze Sponsor at the World Drug Safety Congress America 2015, 22-23 April, Chicago, USA. The event will be held at the Hyatt Regency McCormick Place - Chicago.

    For more information contact us at info@symogenlimited.com
  • 22 APR

    Dr. Pipasha Biswas, Signal Management to Preparation of Product Labels at the World Drug Safety Congress America 2015

    SYMOGEN,  one of the world’s leading pharmacovigilance service providers is pleased to announce that Dr. Pipasha Biswas, Executive Director at SYMOGEN, will speak Signal Management to Preparation of Product Labels at the World Drug Safety Congress America 2015, 22-23 April. The event will be held at the Hyatt Regency McCormick Place - Chicago.

    For more information contact us at info@symogenlimited.com

What They Say

"Excellent knowledge in pharmacovigilance especially in Signal Detection and Risk Management. Approachable and executes work meticulously, accurately and on time”
Senior Safety Science Leader, Roche Pharma
"Deep understanding of safety risk management; is a real asset to companies needing pharmacovigilance support."
President & CMO, Glenmark Pharmaceuticals
"Professionals with an abundance of pharmacovigilance experience used to produce quality work in a timely fashion. Symogen values success of the team and is genereous in sharing their experience, knowledge and time."
Director, International PV, Eisai
"Expert knowledge of PV, enthusiasm, leadership & excellent skills."
Senior Pharmacovigilance Manager, Astellas Pharma

Current Vacancies

Working for Symogen offers you a unique opportunity to gain experience and develop skills in the Pharmacovigilance sector.
With a scope for versatility, initiative and creativity in a stimulating and supportive environment.

At the moment there are no open positions

Our Offices

Symogen UK - HQ




8 Boston Drive, Bourne End Buckinghamshire, SL8 5YS +44 (0) 1628 566511 / +44 (0) 1628 525602 info@symogenlimited.com

Symogen UK - Office





Unit J, Bourne Park, Cores End Road, Bourne End, SL8 5AS +44 (0) 1628 878322 info@symogenlimited.com

Symogen Inc. (Subsidiary) - US Office




1 Woodbridge Center, Suite 215. Woodbridge, NJ 07095 +1 732-912-2200 info@symogenlimited.com

Symogenesis (Subsidiary) - India Office






1003, 10th Floor, Tolstoy House, Tolstoy Marg, Connaught Place, 110001 New Delhi +91 11 43504683 info@symogenlimited.com

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8 Boston Drive, Bourne End, Buckinghamshire, SL8 5YS +44 (0) 1628 566511 / +44 (0) 1628 525602 info@symogenlimited.com symogenlimited.com