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Services

1. Bioequivalence / Bioavailability studies
(More Than 100 submitted)		 2. Clinical Trials (more than 30 submitted)
Excess with more than 40 sites all over India.
3. Dossiers
(more than 40 submitted)		 4. Toxicity study & reports
(more than 12 submitted)
5. PSUR (Periodic Safety Update Reports)
(more than 10)		 6. Medical Transcription & Writing
(more than 10)
7. Medical Rational of Drugs
(more than 15)		  

Bioequivalence / Bioavailability studies

Our clinical researchers, Pharmacokinetics, pharmacologists, statistician and software specialists design the scientific studies and they are responsible for collection and analysis of data in order to evaluate the plasma concentration of the drugs required for regulatory authorities.

Salient features of Clinical Facility:

  • » A clinic with 28 beds facility and an ICU.
  • » Separate Screening, Drug storage, entertainment, dinning and phlebotomy area.
  • » A team of GCP-trained professionals.
  • » Standard Operating Procedures to comply with GCP.
  • » Independent Ethics Committee.
  • » Extensive database of subjects.
  • » Accredited /certified laboratories.

What we do :

  • » Protocol Development
  • » CRF Designing
  • » Statistical Analyses & Interpretations.
  • » Study report generation as per the regulatory requirement.

Design and Conduct of:

  • » Single Dose / Multiple Dose Studies
  • » Single Dose Multiple Periods Crossover Studies
  • » Fasting and/ Fed studies
  • » In-House and/Ambulatory studies
  • » Dose Proportionality Studies
  • » Cross over and/Parallel studies

Salient features of Bio-Analytical Facility:

  • » Well equipped with automated HPLCs
  • » Full range of detectors (UV, Fluorescence, ECD and RI)
  • » Well qualified and trained scientists
  • » LC-MS and LC-MS/MS
  • » Solid Phase extraction system
  • » Refrigerated centrifuge
  • » -20ºC Deep freezer facility.

What we do:

  • » Sample processing
  • » Method feasibility: Enabling the identification of most appropriate method for the detection of the drug in biological samples
  • » Method development: Utilizing scientific expertise to develop methods specific for drugs.
  • » Method validation: In accordance with the regulatory guidelines, validation criteria are compliant, ensuring a robust and reliable assay that delivers sensitivity and selectivity.
  • » Revalidation of the assay method
  • » Biological sample analysis of drugs and / or metabolites for pre-clinical and clinical studies
  • » Stability studies as per ICH guidelines for parameters.

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Clinical Trials

Alpha Laboratories has acquired the experience to create optimal study designs and develop protocols for research programs that extend from dose-finding safety and efficacy studies to large sample-size registration trials and pharmacoeconomic evaluations. Our personnel have the experience and the knowledge in all areas of clinical research, biostatistics, and regulatory issues to provide consultative recommendations or lead the design of your study as required.

From protocol design and feasibility assessments through final study report clinical research services include global phase I-IV clinical trial management, post-marketing studies, safety surveillance & registries, as well as regulatory and product registration support.

From protocol design and feasibility assessments through final study report clinical research services include global phase I-IV clinical trial management, post-marketing studies, safety surveillance & registries, as well as regulatory and product registration support.

Key Activities :

  • » Clinical Trial Services and Consulting (Phase I-IV)
  • » Site Identification / Investigator Recruitment / Feasibility Assessments
  • » Study Setup (including investigator/hospital contract management)
  • » Regulatory and Ethics Committee Submissions.
  • » Monitoring
  • » Project Management
  • » Auditing
  • » Organizing of Investigator Meetings and Congresses
  • » Identification of Pre-Clinical and Phase I Units
  • » Local/Country Specific Lab Identification
  • » Bio-Medical and Pharmaceutical Research
  • » Scientific Expertise and Consulting
  • » Bio-Medical and Pharmaceutical Consulting (including marketing and product registration)
  • » Veterinary Medicine studies
  • » Study Design and Protocol Development
  • » Clinical Trial and Site Management
    • - Research site selection and evaluation
    • - Investigators' meetings
    • - Personnel training
    • - Site initiation
    • - Site set-up and training for (EDC) Electronic Data Capture
  • » Site Monitoring
    • - Source data validation
    • - Checking internal consistency of CRF data
    • - Data query management
    • - Issuing Data Alerts to CDM
    • - Monitoring of enrollment rate and patient eligibility criteria
    • - Drug accountability
    • - Site closure
  • » Project Management
    • - Research site liaison
    • - Progress and status reports
    • - Tracking CRFs and DCFs
    • - Medical monitoring and reporting of Serious Adverse Events
    • - On-site support and Help-desk for o Study Design
    • - Phase I/II safety and dose finding studies
    • - Phase II exploratory efficacy trials
    • - Randomized controlled phase III trials
    • - Phase IIIb and IV trials
    • - Pharmacokinetic and dynamic studies
    • - Bio-equivalence and therapeutic equivalence trials
    • - Pharmacovigilance and pharmacoeconomic trials
  • » Protocol Development
    • - Statistical planning (sample size estimation, randomization, and power calculations)
    • - Complete protocol development
    • - Case Report Form design
    • - Literature review and meta-analysis
    • - CRF completion guidelines
    • - Client representation or support at regulatory meetings (INDs NDAs)

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Regulatory Toxicology

  • » Regulatory toxicological studies on APIs as per DCGI's Schedule Y guidelines.
  • » Acute toxicity studies ( LD50 determination ) in mice by oral and parenteral routes of administration.
  • » A team of GCP-trained professionals.
  • » Sub-acute ( 28 day ) Toxicity Studies in rat and mice.
  • » Chronic Toxicity Studies in rat and mice.
  • » Primary Skin Irritation Studies in Rabbits.
  • » Mucous Membrane Irritation Studies in Rabbits.
  • » "Undue Toxicity" tests on Pharmacopoeal Injectable dosage forms.
  • » Allergenicity and photosensitization tests on topical dosage forms.
  • » Biological tests of safety on products as per BIS specifications.
  • » Statistical Analyses & Interpretations.
  • » Study report generation as per the regulatory requirement.

Data Management & Biostatistics

Alpha Laboratories biostatics and data management department provides impeccable , all-inclusive service to support your project needs ,from initial planning stages through to final database, statical analysis and reporting.

The department's service includes:

  • » Protocol development
  • » Statical programming and analyses
  • » Interpretation and reporting of data for clinical trial reports and publications
  • » Flexible data-capture capabilities based on specific project requirements validated software for data compilation, review and cleanup.

Regulatory Affairs

The drug regulatory affairs fairs group offers regulatory services for human and veterinarian medicinal products such as new active ingredients, generics, herbal medicinal products and biotech products.

  • » Advice on regulatory requirements and application strategies
  • » Negotiations with the authorities
  • » Preparation of all parts of a registration dossier
  • » Compilation of registration dossiers in any format, especially as common technical document (CTD)
  • » Follow-up of submitted documentation
  • » Dealing with deficiency lists and variations
  • » Preparation of drug master files
  • » Applications of certificates of suitability
  • » Allergenicity and photosensitization tests on topical dosage forms.
  • » Expert opinions and reviews, especially for regulatory compliance
  • » Medical Writing.

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