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Laan Research Private Limited

Hyderabad, Telangana

| GST  36AACCL2053M1ZG

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The increasing regulatory and economic challenges of global therapeutic development are creating a desire for quality and value propositions in the emerging markets. How does a sponsor company choose a Pharmacovigilence partner to ensure their products have a long life cycle? The answer lies in a speciality contract research organization (CRO) like LAAN Research with focused expertise in drug and device safety development. Let us create a solution that ensures accurate data with better value. Our ethically based teams deliver timely results while ensuring that quality and value are the highest priority. Our experience in Phase 1 to 4 studies will help us identify efficient and reliable trial sites in international markets, plus our global regulatory expertise will help you navigate your product's path to approval.+ Read More

Nature of Business

Service Provider

Legal Status of Firm

Limited Company (Ltd./Pvt.Ltd.)

GST Number

36AACCL2053M1ZG

Pharmaceutical & Device
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Pharmaceutical & Device

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LAAN Research has experience in every aspect of Clinical Trial Development, everything from the initial protocol writing all the way through to the post marketing trial.  We provide in-depth knowledge and experience in running Phase I, II, III, IV and post marketing trials, as well as the important first in mans.

Protocol Development

At the beginning of a trial, the protocol development must be linked to a clinical plan that supports the product’s strategy, population safety and epidemiological factors. LAAN Research has helped develop protocols and clinical investigational plans for numerous international trials.

Phase I

Being the first stage of testing on humans, we take great care to ensure that the trials are run appropriately and that the safety of the subjects is of primary importance.

Phase II

LAAN Research has helped conduct several Phase II trials in different fields to see how well the investigational product performs in the therapeutic area that it is intended to treat.

Phase III

Randomized clinical trials (RCTs) provide the safety and efficacy data for regulatory submissions.

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Regulatory reporting to the global authorities

  • FDA, Japan (PMDA), BPharm (Germany), MEDDEV and device deficiency reporting for European Regulatory agencies, New Zealand, Australian regulatory authorities and India (DCGI)
  • IFU (Indications for Use) generation for products
  • Label and package inserts
  • Signal investigation & trending of MedDRA coded events
  • Includes UADE (Unanticipated Adverse Device/Drug Event) review and Rare Event review
  • Health Hazard Assessments for device products and Risk Assessments

• FDA and CA submissions, negotiations and responses

Clinical Evidence Reports (CERs)

The Medical Device Directives of the European Commission mandate that products with CE Mark approval in the EU must establish and maintain clinical evidence regarding the safety and the performance of their products throughout their life cycle. Therefore, clinical evidence reports (CERs) are a requirement for products sold in Europe.

LAAN Research has a good understanding of the requirements of clinical evidence and can help a sponsor create and maintain CERs that encompass new clinical use data, emerging post marketing trial data, safety, and data handling complaints.

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