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Sourcing Inquiry Logo Semler Research Center Pvt Ltd

Semler Research Center Pvt Ltd

Regions
North America, Asia
Countries
India, United States
Size
n.e.
Specialty
Human Medicines, Biopharmaceuticals, …
Specialty
Human Medicines, Biopharmaceuticals, Generics
Service category
Pharmaceutical process development and validation, Formulation development and drug delivery, …
Service category
Pharmaceutical process development and validation, Formulation development and drug delivery, GCP audit services, Quality management services, Pre-clinical development and testing, pre-clinical CRO, Clinical development and testing, clinical CRO, Analytical laboratory and testing services, Regulatory services - CMC writing - medical writing, Others
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Key services

Services

Pharmaceutical Development

SRC offers a full spectrum of pharmaceutical development services from pre-clinical stage through early-phase & late-phase clinical studies to commercial manufacturing. Our mission is to provide on-time delivery of superior quality formulations in the right quantities at the best price to our customers. From early phase development to ANDA formulations, we bring decades of global expertise and state-of-the art facilities to meet our client specifications with punctuality, precision and rigor.

 

Formulation & Analytical Development

Formulation Development
Our expertise in formulation development extends to the development of all conventional dosage forms. Our strategic alliances broaden the scope to consider many Novel Drug Delivery Systems (NDDS), including transdermal & liposomal delivery systems. We consider multiple approaches to improve the bioavailability of drugs. We are constantly expanding our capabilities, including in our repertoire additional modules and suites to develop a CACO-2 cell membrane permeability study laboratory.

Collectively, we have the experience to formulate oral solids, dermatologicals, ophthalmic suspensions and ointments, expertise in improving delivery of poorly soluble/ permeable drugs and the capability to screen potentially innovative drugs based on pharmacokinetic properties. We possess pelletization, drug-layering, particle-coating and other technologies to achieve extended release profiles for tablets or capsules.


Analytical Development
Our analytical development services include assay and RS method development and validation, dissolution method development and validation, stability studies as per ICH guidelines, polymorphic form characterization (DSC/TGA/XRD/Microscopy), cleaning validation studies and HPLC to UPLC method conversions.

Generics and NCEs
  • Pre-formulation
  • Proof of Concept
  • Phase Appropriate CT Formulations
  • Process Development Studies
  • Scale-up and Technology Transfer
  • Commercial Process / Formula Development
  • CACO-2 Cell Permeability Studies
  • Life cycle management
  • Differentiated generics, 505 (b) (2)
 Dosage Forms
  • Tablets – Immediate Release, Modified Release
  • Capsules – Immediate Release, Modified Release
  • Oral Liquids / Suspensions
  • Injectables and Ophthalmics – Liquids / Suspensions
  • Topicals – Ointments / Creams / Gels
  • NDDS
    • Liposomes
    • Transdermals
    • Liquid filled hard gelatin capsules

Pre-Formulation

Semler Research Center recognizes pre-formulation as a critical phase in the drug development cycle and has developed a basket of services that ranges from scientifically justified experiments for salt selection to establishing chemical specifications for the active pharmaceutical ingredient (API).

Physicochemical tests conducted during discovery and lead optimization using advanced analytical techniques – DSC/TGA/XRD and so on - enable rational decisions for compound, salt or polymorph selection that maximize the probability of compound success and are essential to the establishment of a sound intellectual property position.

Upon thorough understanding of the physico-chemical properties of the API, the development routine will include characterization of API – excipient mixtures, materials of construction effects, process variables that affect API or formulation attributes.

Pre-Formulation Services
  • Physico chemical evaluation
  • Solubility studies:
    • pH dependent aqueous solubility
    • solubility in co-solvents
    • surfactant assisted solubility
    • equilibrium solubility
  • Intrinsic dissolution study in various pH conditions
  • Salt design/screening and selection
  • Dissociation constant redetermination
  • Partition coefficient and log P determination
  • Polymorphism studies
  • Particle size, surface area, bulk/ tapped density determination
  • Particle size distribution
  • Bulk/tapped density determination
  • Binding constant determination
  • Drug-excipient compatibility studies
  • Containers:
    • Closure integrity testing
    • Rubber stopper & tubing compatibility
    • Filter compatibility
    • Stress stability
    • Photo stability
    • Hold-time study
 

Pre-Clinical

Semler Research Center, in strategic collaboration with state-of-the-art, GLP compliant pre-clinical facilities, can design and implement comprehensive studies for NCEs and biologicals from lead to phase clinical studies.

Our formulation capabilities include:
  • Proof-of-concept and prototype formulations for early stage animal studies as drug discovery support
  • Bio-analytical support for animal pharmacokinetics and bioavailability studies
  • Screening of potential formulations prior to pilot bioequivalence studies in human volunteers using CACO-2 cell permeability studies or animal studies

In addition, we conduct toxicology studies including in vitro genetic testing (Ames, Chromosome Aberration, Micronucleus) and in vivo studies that include acute to chronic toxicity, carcinogenicity, development and reproduction studies, safety pharmacology (core battery), micro-dosing (phase 0), immuno-toxicology (core battery) and environmental risk assessment.

We also offer customized studies to profile drug candidates or metabolites in vitro and in vivo. Our animal models include rodents and non-rodents (rat, mouse, rabbit, guinea pigs& dog) using all common routes of administration.

 

Phase I, II & III

Semler Research Center (SRC) has in-depth expertise and an unsurpassed attention to detail in developing formulations of new chemical entities for the manufacture of phase I, II and III clinical supplies for US, European, Indian and other regulatory submissions.

We have the capabilities for preparing small scale batches for first-in-human (FIH) or proof-of-concept (PoC) studies, Active Pharmaceutical Ingredient (API) characterization & salt specifications, manufacturing of feasibility batches, Clinical Trial Material (CTM) manufacturing, packing to Good Manufacturing Practice (GMP) specifications and early phase stability studies in High Density Poly Ethylene (HDPE) bottles in blister packs. Our deep expertise in early phase formulations & analytical services greatly reduces the chance of failure and avoidable rationalizations during regulatory submissions.

Our clinical development support extends to Phase II & III related formulation development to finalize the trade dress of your formulation. We provide complete analytical validation as per ICH guidelines, develop discriminating dissolution media and support scale-up, process optimization & validation and the manufacture of exhibit batches. We complete the loop by providing the final product specification for Quality Control (QC) and a well-defined process for the design and review of Chemistry, Manufacturing and Controls (CMC).

Phase I
  • Small scale formulation for FIH/PoC study
  • Tentative specifications for API
  • Manufacturing of feasibility batches
  • CTM manufacturing and packing as per GMP with strategic partners
  • Early phase stability studies in HDPE bottles and various blister packs
 Phase II & III
  • Formulation development finalizing the trade dress of the formulation
  • Complete analytical validation as per International Conference on Harmonization (ICH) guidelines
  • Development of discriminating dissolution media
  • Scale-up, process optimization & validation and manufacture of exhibit batches
  • Final product specification for QC
  • CMC support
 

ANDA

The global pharmaceutical industry is at an inflection point. With many of the blockbuster drugs getting off patent and with increasing R&D costs, it is hard for companies to maintain their bottom-line and remain unaffected. Semler Research Center not only possesses the tools, expertise and assets to support our clients' ANDA submission efforts, we also have a strong commitment to optimize our operational costs and processes in a way that most benefits them in bringing low-cost drugs to market faster and cheaper. We possess the added advantage of offering ANDA services within an independent setting that is free from liaisons with any pharmaceutical company.

Our team of seasoned 'generic' specialists is adept at developing formulations to match Reference Listed Drug (RLD) specifications, combined with accurate analytical development and skilled technology transfer. We also undertake compilation of Complete Technical Document (CTD) dossiers, are familiar with electronic filing and can support our clients with regulatory global submissions for generic drug product approvals across the globe.

ANDA Service Highlights
  • Analytical development and validation based on ICH guidelines
  • RLD evaluation
  • Drug excipient interaction studies
  • Formulation development to match the dissolution properties of RLD in OGD and multimedia dissolution
  • Accelerated stability in primary pack along with RLD
  • Identification of critical process parameters and process optimization, and scale-up
  • Technology transfer
  • Bio-batch or exhibit batch manufacturing with strategic partners

Bioavailability & Bioequivalence

Semler Research Center (SRC) offers two state-of-the art pharmacology centers in India to conduct early phase pharmacological and drug developmental studies. We leverage the team's combined experience of over 50 years in conducting over 750 drug studies ranging in size from 40-400 volunteers in various therapeutic areas for various regulatory submissions. SRC serves the bio-pharmaceutical market by conducting quality bioavailability & bioequivalence studies both economically and efficiently.

Our services are end-to-end and customized to meet each client's specific requirements. The studies are ably supported by our bio-analytical team with in-depth expertise in generating methods that are accurate, precise, selective, sensitive and reproducible. Our proficiency is constantly upgraded to meet evolving requirements for various approvals, including novel therapeutic drugs, generic drugs and post–approval formulation changes. We have over 200 methods readily available. The bioanalytical team also supports complex pharmacokinetic studies in patients conducted by the clinical development team for early exploratory, investigative or screening studies which support regulatory submissions.

Clinical

SRC is equipped to handle the full spectrum of early phase studies from two centers in India, offering access to vast volunteer pools and excellent turnaround times at economical costs. In collaboration with a number of specialized clinical centers, we also undertake complex pharmacokinetic studies in patient populations.

Our two centers put together can accommodate up to 400 volunteers. Our volunteer database exceeds 10,000 at each center and is constantly updated.

Our systems and processes are SOP driven and in sync with global procedures and practices and assure the highest level of data quality and safety to volunteers.

Additionally, we provide our clients with a dedicated project management team to serve as a single point of contact and who assists in all aspects of the clinical studies and ensures timely and high quality execution of each project.

Formulations
  • Oral – tablets, capsules, disintegrating tablets, suspensions
  • Sub lingual
  • Intramuscular
  • Intravenous
Routes of administration
  • Routine systemic
  • Dermal/topical
  • Ocular
  • Infusion
  • Intra-arterial
  • Intra-nasal
  • Intra-thecal
  • Intra-tracheal
  • Intra-intestinal
  • Intra-rectal
  • Intra-vaginal
  • Intra-vesicular

Bioanalytical

Semler Research Center (SRC) offers a well-equipped bioanalytical laboratory with an uncompromising commitment to producing studies of the highest quality, completed to your specifications and timelines and that meets the most stringent regulatory requirements across the globe.

Each study is overseen by a study director who monitors all phases of the project, from receipt and inventory of reference materials and samples to preparation of the final report. We ensure that each client has direct access to the scientist who is closely involved with your project.

Strict security and confidentiality policies and procedures are applied to all analytical work to ensure that our clients receive services that match the highest levels of compliance. Our methods are developed and validated in accordance to GLP and ICH/FDA guidelines.

Key Bioanalytical Services
  • Method development
  • Method validation
  • Method transfer
  • Analysis of in vitro ADME and in vivo PK/ADME samples by HPLC and LC-MS/MS
  • Analysis of drug and metabolites in different biological fluids by HPLC and LC-MS/MS
  • Analysis of toxico-kinetic study samples by HPLC and LC-MS/MS

Pharmacokinetics & Pharmacodynamics

Semler Research Center (SRC) offers pharmacokinetic (PK) and pharmacodynamic (PD) services to describe the time course of individual exposure and response to a new treatment. Studies are conducted to establish therapeutic schedules, evaluate their relevance, or evaluate dose adjustments in particular patients. Our capabilities in PK include early exploratory, investigative or screening studies, which support regulatory submissions.

Our Pharmacokineticists work closely with our statistical, scientific writing and bioanalytical staff at every stage of the study. From initiation to completion and reporting, they ensure a smooth and effective transition of high-quality pharmacokinetic data from our bioanalytical laboratory to the pharmacokinetics department and then to our statistical and medical writing groups and finally in the preparation of comprehensive ICH compliant reports.


PK and PD in Patients

SRC offers a complete range of research services in the area of pharmacokinetic and ADME studies for small molecules, large molecules, biologics and other related test articles and devices. The studies are conducted to establish therapeutic schedules, to evaluate their relevance or for dose adjustments in particular patients.

 

Key PK & PD Offerings
  • Input into study design, including pre-clinical-to-clinical considerations (allometric scaling) utilizing information from pre-clinical toxico-kinetic studies
  • Non-compartmental pharmacokinetics
  • Compartmental pharmacokinetics/simulations
  • Ascending dose (assessment of dose proportionality)
  • Repeat dose (assessment of steady-state kinetics and multiple dose linearity)
  • Bioavailability and bioequivalence
  • Drug interaction studies
  • Special population studies
  • Pharmacodynamic and PK/PD modeling
  • Deconvolution
  • Comprehensive text interpretation of data

 

Clinical Development

Semler Research Center (SRC) offers clinical development services which comprehensively includes a mix of innovative clinical research solutions addressing clinical development plans, protocol designs, regulatory consultation and strategy, project management & monitoring services, data management & biostatistics, clinical supply management and archival services to address the current and emerging needs of the pharmaceutical, bio-pharmaceutical, device and diagnostic industry.

Based on a broad therapeutic experience and keen insight into the local and global regulatory requirements, SRC conducts clinical studies locally, regionally and globally, supported by electronic & online solutions such as Interactive Voice Response Systems, Electronic Case Report Forms, Electronic Patient Diaries and Clinical Trial management Systems.

As an integrated clinical development service provider, we focus on providing innovative approaches to planning and conducting clinical studies across all phases of development within a framework of competitive budgets and efficient execution methodology. From clinical concept to clinical study report, the SRC team has the ability to handle large-scale clinical projects from site selection, initiation, patient recruitment, supply management and monitoring, to data capture, analysis and reporting — while providing due personal attention towards strategy, planning, conduct, oversight and communication.
 

Project Feasibilities

Semler Research Center (SRC) studies the viability of each study protocol or clinical study outline through a disciplined and documented process. The feasibility is conducted at three levels – operational, technical and economical - to ensure a thorough examination of all issues related to conducting the study in India and other applicable regions. The feasibility team seeks inputs from leading consultants and experienced Investigators in relevant therapeutic areas, especially for complex protocols. A factual assessment of potential and Investigator sites, recruitment rates, viable investigator grants, expected challenges to a study protocol, as well as suitable mitigating plans enhance the probability of a successful project.

 

Project Management

The project planning and management team at Semler Research Center (SRC) comprises of qualified and trained project managers and clinical team leads with extensive experience in managing Phase I to IV studies for regulated markets. Besides skill and experience, all projects rely on a strong process that defines each activity and its outcome. SRC's SOPs are well aligned both with regulatory norms as well as with best practices of the industry to provide the best results. The interdisciplinary team consisting of medical, pharmaceutical and life sciences graduates forms the delivery team under the guidance of the project manager.

Crucial components addressed within project management include:

  • Project planning & implementation (PMP)
  • Overall project communication
  • Investigator meeting management
  • Risk management & contingency planning
  • Resource planning and management
  • Patient recruitment & retention strategies
  • Investigator contract negotiation and execution
Study Monitoring

Semler Research Center (SRC) ensures adequate monitoring as an imperative process for conducting a safe and successful study. For each phase of the project, SRC ensures the sponsor is provided with a timely, complete and detailed report after each monitoring activity undertaken.



Pre-study Qualification Visits

Extensively assess each clinical research site for its ability to conduct the study in the highest degree of compliance with the protocol, applicable regulations, Good Clinical Practices (GCPs) and the overall conduct of clinical studies.


Site Initiation Visits

SRC facilitates all set up activities and conducts a detailed training which aims at preparing the site for the first patient enrollment. Training includes but is not limited to, review of protocol, regulatory documents, case report forms, enrollment and retention requirements, investigational drug management, safety reporting and responsibilities for the conduct of the clinical study.


Ongoing Monitoring

SRC conducts ongoing clinical monitoring throughout the conduct of the clinical study defined by a meticulously drawn monitoring plan that includes thorough checks on completed informed consents, protocol inclusion and exclusion, case report form and source documentation, data retrieval, regulatory documents, protocol adherence, safety reporting to institutional review boards and drug accountability.

Site Close Outs

Upon completion of the clinical study, SRC provides final retrieval of all data, resolution of data clarification queries, assessment of regulatory documents, review of site regulatory obligations, investigational drug accountability and return in a final re-conciliation and conclusion visit.


Safety & Medical Monitoring

Safety and medical monitoring is provided by physicians who have adequate clinical experience and/or safety management of the related therapy area. Our medical monitors provide necessary support for each protocol that include addressing medical queries, imparting protocol training, interpretation of subject's eligibility, tracking subject safety during ongoing studies, identifying safety signals and safety trends and analyzing and receiving, reviewing & reporting of safety information.

 

IP Management

Semler Research Center (SRC) ensures complete protection of investigational products by providing secure storage under ambient refrigeration and deep freezer conditions backed by round-the-clock temperature logging with online sharing of temperature records.

We have two well-controlled pharmacies in India from which we dispense your product under protocol-specific temperature requirements across the country. Additionally, SRC provides IVRS/IWRS supported clinical supply management services which include randomization, preparation of envelopes, drug dispensing and tracking.

The IP management services of SRC can be either accessed as a part of a study project or be used as an exclusive service on a standalone basis.

Approvals, Certificates, Authorisations

  • Health Canada
  • EMEA
  • MHRA
  • WHO
  • Ich
  • GCP
  • DCGI
  • US FDA

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