HiTask Laboratories

First time right Solutions to all Pharma and Medical Device Manufacturers.

Helping them produce High quality products at optimum costs with quick turnaournd time.

Our Services

ANALYTICAL TESTING SERVICES

  • Process risk assessment (method development, Validation and release testing)
  • Nitrosamine impurities assessment in raw materials, intermediates, API and finished dosage forms.
  • Elemental impurities as per ich q3d and other heavy metals from the manufacturing process and facilities including container and closure systems.
  • Impurity cut off studies for the new and existing pharmaceutical and medical device products at manufacturing/lab scales.
  • Extractable and leachable studies for the product and its packing and labeling materials.
  • Glass delamination studies for the finished dose forms.
  • Genotoxic impurity identification and quantification.
  • Impurity profiling for medical devices.
  • Batch release testing with necessary good laboratory practices.
  • Characterization and qualification of reference and working standards

ANALYTICAL TESTING PLATFORM

  • Analytical techniques stated below shall be used for the services in addition to routine qc techniques:
    • GC-MS/MS (gas chromatography with mass spectrometry)
    • ICP-MS (inductive coupled plasma with mass spectrometry)
    • LC-MS/MS (liquid chromatography with mass spectrometry)
    • HPLC – UV/RI – (high performance liquid chromatography)
    • GC – HS/ALS (gas chromatography with headspace and auto injectors).
  • Service activity handled at newly created facility located at j n pharma city, thanam, parawada and other collaborated laboratories under expertise support from HiTask team.
  • Impurity profiling for medical devices and pharmaceutical products.
  • Leachable & extractable studies for packing and labeling materials.

 

SPECIALIZED CUSTOMER SERVICES

  • Support to all manufacturing and research & development customers for
  • New laboratory set up and qualifications with right model and make instruments and computerized systems and good laboratory practices.
  • Qc laboratory operational excellence and cost reduction.
  • Laboratory investigations at laboratory shop floor.
  • Technical report writing.
  • Analytical method and technique trouble shootings and life cycle management.
  • Computer system gap analysis and validation with 21 cfr part 11 compliance support.
  • Customer and regulatory inspections handling.
  • Customer complaint and regulatory deficiency handling.
  • Technical trainings and skill development at our excellence center/customer sites.
  • Analytical expertise consultancy to all pharmaceutical manufacturers for regulatory and key customer approvals.

Why to Choose HITASK Labs?

HI-TASK ANALYTICAL SERVICES TEAMS EXPERTISE IN ANALYTICAL AND QUALITY SYSTEMS WITH
EXPERIENCE OF CUSTOMER SERVICE CAN UNDERSTAND AND SUPPORT FOR THE BUSINESS DEVELOPMENT OF PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRIES.

• EXPERTISE TEAM CAN SERVE WITH ADVANCED ANALYTICAL TECHNOLOGY WITH NECESSARY
QUALITY AND COMPLIANCE SYSTEMS.

• AFFORDABLE AND EFFECTIVE TURN AROUND TIME FOR THE SERVICES CAN RESOLVE CUSTOMER CHALLENGES TO PRODUCE HIGH QUALITY PRODUCT AT LOW PRODUCTION COSTS.

• HI-TASK TEAM COMMITTED TO PROVIDE FIRST TIME RIGHT SOLUTIONS FOR ALL SMALL TO
LARGE SCALE PHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURES.

Our Leadership Team

CH B V NARASIMHA RAJU, PHD

CH B V NARASIMHA RAJU, PHD

Key Promoter

  • PHD in analytical chemistry from Andhra university.
  • International publications in reputed journals like springer and Informa world etc.
  • Board of studies member in Andhra university and Dr. BR Ambedkar university.
  • Research guide to Andhra university for PHD programs.
  • Advisory board member for Indian pharmacopoeia commission for drug substance monographs
  • Relevant experience in the field of drugs and pharmaceuticals industry •
  • 23 years’ experience in pharmaceutical quality system and analytical research positions at the global generic companies like Teva pharmaceuticals, Dr. Reddy’s laboratories ltd, Mylan laboratories ltd. and Aurobindo pharma ltd.
  • Expertise in pharmaceutical quality system & impurity profiling using all advanced analytical techniques for elemental impurities and nitrosamine impurities in drug substance and all types of finished dosage forms.
  • Handling of regulatory inspections.
  • Experience in leachable and extractable studies for sterile pharmaceuticals.
  • Laboratory computer system validations and compliance of 21 CFR part 11.
  • Shop floor capability building with operational excellence to save the cost of testing and manufacturing of quality products to compete with large scale manufacturers across globe.
P. L. SRIDHARARAO

P. L. SRIDHARARAO

Co-Promoter

  • M. Sc. in organic chemistry from Sri Krishna Devaraya university
  • Relevant experience in the field of drugs and pharmaceuticals industry
  • 14 years of blend experience in third party testing laboratory, analytical research and pharmaceutical quality systems. Worked for Vimta labs ltd, Laila nutraceuticals ltd and Dr. Reddy’s laboratories ltd.
  • Customer service experience to all matured regulatory markets like USA, Europe & Canada and all emerging markets.
  • Successfully involved in the NABL audits which are governed as per iso:17025 and also audits performed by export inspection council of India (eic).
  • Handled analytical function with all advanced technology like NMR, LC-MS/MS, GC-MS and ICP-MS etc for method validations and release testing of drug substance, oral solid and topical dosage, sterile injectable, ophthalmic and inhaler products.
  • Expertise in pharmaceutical impurity profiling including elemental impurities, nitrosamine impurities and other genotoxic impurities in drug substance and all finished dosage forms.
  • Expertise in characterizing the unknown peaks reported in ds and dp by using LC-MS/MS and GC-HS/MS.
  • Experience in leachable and extractable studies and glass delamination studies for sterile pharmaceuticals.

About US

HI-TASK ANALYTICAL SERVICES PVT LTD IS A SERVICE AND SUPPORT BASED COMPANY ESTABLISHED ON 22ND OCTOBER 2020.

  • PROVIDING ANALYTICAL METHOD VALIDATIONS AND RELEASE TESTING SERVICES AT STATE OF ART TESTING FACILITY LOCATED AT JN PHARMA CITY, PARAWADA, VISAKHAPATNAM.
  • CATERS TO ALL PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRIES FOR ANALYTICAL RESEARCH AND DEVELOPMENT, RELEASE TESTING AND CUTOFF STUDIES FOR TOXIC IMPURITIES (PROCESS RELATED, ELEMENTAL, GENOTOXIC, EXTRACTABLE AND LEACHABLE IMPURITIES ETC.) WITH ADVANCED TECHNIQUES LIKE GC-MS/MS, ICP-MS AND LC-MS/MS ETC.
  • SUPPORT TO ALL QC LABORATORIES OF PHARMACEUTICAL MANUFACTURERS FOR LABORATORY OPERATIONAL EXCELLENCE AND COMPUTER SYSTEM VALIDATIONS.
  • SUPPORT TO ALL API AND INTERMEDIATE MANUFACTURERS FOR THE IMPROVEMENT OF QUALITY AND COMPLIANCE.
  • SUPPORTS TO CONTRACT MANUFACTURING SITES FOR THE TECHNOLOGY TRANSFER AND IMPLEMENTATION.
  • EXPENSIVE ANALYTICAL TECHNOLOGY WITH EXPERTISE TEAM CAN BE REACHED TO EVERY SMALL TO LARGE SCALE PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRY WITH REASONABLE COSTS AND EFFECTIVE TURN AROUND TIMES TO IMPROVE AND DELIVER THE QUALITY PRODUCTS.
  • SUPPORT CUSTOMERS TO IMPROVE THE INTERNAL COMPETENCY OF PEOPLE WORKS AT PHARMACEUTICAL INDUSTRY SHOP FLOOR TO UPDATE THEIR KNOWLEDGE AND SKILLS AS PER CURRENT PHARMACEUTICAL INDUSTRY STANDARDS AND NORMS FOR THE EXPORT AND INDIGENOUS MARKETS.

Phone

9618699855

Location

HI-TASK ANALYTICAL SERVICES PVT. LTD.

31-39-11-43/9, SRI SAI NAGAR, NEAR ABDUL KALAM PARK, VUDA PHASE 1, KURMANNAPALEM, VISAKHAPATNAM – 530046.

Email

marketing@hitasklabs.com