It is very nice to visit Lambda facility and thanks to warm welcome provided by all the teams. I can easily say one of the best CRO I ever visited. People here are wonderful and doing great job

Reputed Client of Israel

Awesome hospitality & fantastic office. All the best!

Reputed Client of Japan

Excellent hospitality and cooperation received throughout the audit. People are knowledgeable and extremely transparent. Looking for long time relation

Reputed Client of Asia

Facility is too good to conduct the BABE studies and adherence to protocol and quality assurance in conducting studies are meeting sponsor expectations and requirements.

Reputed Client of India

Facility is good, people r trained well and know the subject on which they r working. All the best.

Reputed Client of USA

Highly innovative and advanced research centre that possess bright future for the development of the country.

Reputed International Government Body

It is one of the best facility in India for BA/BE

Reputed Regulatory Authority

Lambda is a very professional CRO. All the staff here are experienced and very knowledgeable. I'm grateful for their accommodations and hospitality. The future, if we want to carry out BE study, we will ask Lambda help again.

Reputed Client of Europe

It was a really pleasant meeting with the PV department, and I am looking forward to the next visit.

Reputed Client of Europe

Amazing and best CRO I ever seen

Reputed Client of China


Drug Safety & Pharmacovigilance

Home / Services / Drug Safety & Pharmacovigilance

Operations – ‘Hub & Spoke’ Model
Indian PV (Global Back-end Operations)










PV Systems

European Union Qualified Person (EU QP) for Pharmacovigilance and Network of regional LRPVs

  • Single contact point that reviews all deliverables
  • Deputy QPPV
  • 24 x 7 x 365 Coverage
  • Network of Local PV responsible persons per specific NCAs requirements

Pharmacovigilance System Master File (PSMF) – Registration Support

  • Prepare, advise, oversee and co-ordinate the PV system support from 1st submission of Market authorisation and throughout the product's lifecycle
  • Support Module 1.8.1 and 1.8.2 of e-CTD modules
  • Revision and updates to PV systems in compliance with regulations

Contractual arrangements with business affiliates

  • Draft SDEAs customized as per global regulatory requirements and Review of existing SDEAs
  • Exchange of ADRs with business partners after execution
  • Managing 150+ SDEAs with Global affiliates of our clients

Medical Enquiry (including access to medic)

  • Call receipt 24X7
  • Management of standard and off label customer enquiries
  • Management of complete cycle from receipt of enquiries to database and response


Operational Services

Eudravigilance registrations and electronic submissions of ICSRs

  • Through Gateway (both EMA and FDA) or Web-trader
  • Hybrid system capable of both electronic and paper-based submission in multiple regulatory report formats like CIOMS I, Med Watch - 3500A

Periodic Reporting

  • PSURs, PADERs, ASRs, DSURs, PBRER and ACOS as per the regulations
  • Report generation complying to regulatory formats

Literature Monitoring

  • Weekly literature monitoring of Pubmed for identification of ICSRs, Publication studies facilitated by a validated, fully automated software module (LAM)
  • Full text articles procurement
  • Global literature surveillance for 500 active moieties


  • Web-based, customizable and end user-friendly safety database.
  • 21 CFR 11 compliant and based on ICH E2B specification
  • Fully integrated MedDRA and WHO-DD browsers
  • "E2B R2 and R3 compliant" database
  • Additional features like PvD’s Code (Partial automation), Literature automation module and PrITR for medical information
  • Compliant database for Device Vigilance and Vaccine Vigilance

Signal detection, evaluation and management

  • Use of both quantitative measures and qualitative analyses to detect, as soon as possible, any indication of a potential problem with a drug, either a new or an old drug.
  • Experience in almost all therapeutic areas including oncology anti-depressants, biologicals, anti-psychotics…
  • Evaluation of EVDAS (Eudravigilance Data Analysis System) Data during signal detection

xEVMPD compliance solution and Services

  • As key support services, we take care from data collation, data entry, data checking services to EV submissions of XEVPRMs on behalf of our client
  • Experience in almost all therapeutic areas includingoncology anti-depressants, biologicals, anti-psychotics…

Creation and Maintenance of Risk Management Plans (REMS or RMPs)

  • Risk management planning during peri or post-authorisation phase of the product lifecycle
  • Identification of risk minimisation measures and also evaluation milestones ensuring benefits outweigh the risks

Support Services

PV consulting & Training

  • Training PV staff on Global pharmacovigilance legislations and regulations.
  • Recommendations for pharmacovigilance department designing, development and improvement.

Quality Management System (QMS)

  • Setting up of QMS systems and processes in line with ICH guidance and compliance with local regulations

Global Compliance monitoring and audits and support for Inspections

  • Review of the company’s compliance data on a monthly basis
  • Support for management of inspections by global regulatory authorities
  • Support for CAPA execution for the closure of inspection findings


Looking for a Globally Proven Research Partner?

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