FSMS ISO 22000:2005 Certified Company.

Call Us - 0141-2366960
For-Help - pertssciences@gmail.com

We have sister concern PERT PHARMA BPO, engaged in regulatory and other consultancy service for Pharma and Nutraceutical industry.

Our offerings to the industry covers all the essentials needed to complete regulatory processes and market requirements.

Particularly speaking for the need of Nutraceutical industry related to FSSAI we offers

• Obtaining new product approval for Nutraceutical/Ingredients/ Food etc. at FSSAI
• Submitting and obtaining licenses and registration from the FSSAI by food business operators wishing to trade in India, this applies also to obtaining the relevant permissions in local jurisdictions where necessary.

With our knowledge pool & expert team we can assure you timely delivery at affordable cost.For more details about our services you may visit our website www.pharmabpo.com

We have some specialised services for industry Pre Clinical Services

Toxicological Studies
Acute toxicity, chronic toxicity, Neurotoxicity, Genotoxicity, Organ toxicity, Cardiotoxicity, Teratogenecity

Histological Studies
Protocol designing, test selection, review of slides/results (Spine density study in brain TS makes histology department of PBRI as an outstanding laboratory)

Biochemical and Haematological Studies
IL estimation, CRP estimation, Blood insulin estimation, TNF-α estimation, Hemeoxygenase estimation, SOD, GSH, LPO, Catalase, Adiponectin estimation, Acetylcholinesterase estimation, LOX estimation, COX estimation, etc
Receptor Binding Assay
Pharmacokinetic Studies
Pharmacological Investigation

Study of drugs acting on:Cancer, CNS, CVS, Diabetes, Kidney stones, Immunity, Pathogens, Ulcer, Hepatic cells, Drug induced toxicity, Kidney Cells, oxidative stress etc.

Molecular Biology
In joint hands with biotechnology department, pharmacology department provides detail molecular level studies facility for assessing effect of drug at molecular level by using PCR, Blotting and ELISA

Regulatory Affairs
  • Domestic Dossier formation & compilation.
    o Product approval on stability.
    o Product approval on Bio-equivalence/Clinical trial.
    o Any Justification.
    o Process Validation.
    o Analytical Method Validation.
  •  Country specific Dossier formation & compilation.
  •  CTD/ACTD for bulk drugs and dosage forms for export registration.
  •  Certificate of suitability.
  •  Bio-Availability /Bio-equivalence studies.
  •  Toxicological
  • Studies.
Trouble Shooting Solutions for trouble shooting and consultation in -
  • Designing of protocols
  • Manufacturing of formulation
  • Pharmacodynamic studies
  • Toxicological studies
  • Pharmacokinetic studies
  • Preparation of documents for any compliance Medical Writing
  • ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure
  • Study Protocols
  • Clinical and non clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU or US Regulatory Authorities
  •  Investigator Brochures
  •  Patient safety narratives
  •  Patient information including Informed Consent and Patient Brochures
  •  Pharmacovigilance documents such as Periodic Safety Update Reports
  •  Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct and reporting of clinical trials and the outsourcing of Sponsor responsibilities to a Contract Research Organisation (CRO)
Scientific Communicationsss
  • Conference materials (abstracts, poster presentations and slide sets)s)
  • Manuscripts
  • Editorial support
  • Journal/conference submission
  • Product website content (for both scientific and patient audiences)
  • Educational material for patients, healthcare professionals and pharmaceutical industry personnel
  • Medical marketing reviews and reports
  • Literature reviews
  • Publication planning
Marketing Support & Training
  • Marketing Communication, Literature, Visual Aid
  • Market Survey & Market Potential
  • New Product Development
  • Product Launch
  • Conference promotion
  • Product Training for Medico, Social and Online Sale.
  • Sales Training.
  • Field Staff Introduction Training.
  • Scientific training to Field Staff.
  • Job orientation Training.
  • Training to Back-up and Administrative Staff.
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