Exclusive Services

Product Development with focus only on regulated markets like US, Europe, Canada, Australia, South Africa, WHO, etc.

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Six (06) times USFDA Audited and Accepted Analytical lab delivering world class services to more than 150 pharmaceutical companies.

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Largest Resource for Ion Chromatography; Extractable & Leachable studies & USFDA Inspected In-vitro Bioequivalence studies.

• Experience on complete project and clinical management of more than 350 BA/BE studies including 18 patients based PK/PD studies for regulated markets (USFDA, EMA, TGA, ANVISA, etc).

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• Extensive experience of managing clinical studies on a range dosage forms including Oral Solids, Liquids, Transdermal patches, Inhalation Products (MDIs and Powder Inhalers), Injectable Emulsions, Suppositories, Chewing Gum, Sublingual and Oral Films and Implants.

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• Managing Clinical studies on Healthy Male/Female, Geriatric, Post Menopausal Women, Genotype (Slow & Fast Acetylators), etc.

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• Vast Experience on managing clinical biostudies for Narcotics / Psychotropics and/or Controlled Substance (CII) products.

• Extensive experience on Monitoring of PK/PD based Clinical studies viz. COPD, Nicotine Chewing Gums, General Anaesthesia, Psychotropic and Controlled Substances (C II).

 

• Hands On experience with Monitoring of Bioequivalence (Healthy subjects) and Patient based (Phase I, II and III trials).

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• Vast experience of conducting System / Qualification Audits of CROs in India.

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• Capacity Assessment Audits for Specific Product related biostudy requirement (viz. Inhalation, Chewing Gum, etc.).​

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• In-Process Audits for Bioanalytical sample analysis and related activities.

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• Vendor Audits / External Service Facility Audits (viz. Clinical Pathology Laboratory, Catering, Hospitals, etc.)

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• More than 400 audits including API, FDF, CMO and Medical Devices company

 

• More than 21 Clinical CRO audits.

 

• On site Validation batches supervision and compliance.

 

• Preparation of Regulatory Agency Audits for API, FDF and CMO.

 

• GAP Analysis, Correction Actions and Management.

 

• Suggestions on CAPA and Responses to FDA 483, EDQM Observations, etc.

 

• Preparation and Implementation of Quality standards and Quality Management System.

• Module 2 writing for more than 110 products.

 

• Risk Management Plan for 18 products

 

• SmpC Comparison and Preparation for 27 products

 

• Biowaiver Monograph / Write-Ups for 02 product.

 

• Clinical Pharmacology & Toxicology reports for 11 cases.

 

• Abstracts, Posters, Manuscripts, Commercial Brochures and Journal Submissions for 63 cases.

 

• Statistical Analysis Plan for 13 Clinical Trials.

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• Working with different Ex-regulatory (MHRA / USFDA) experts on subject matter concerns.

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• Regulatory Agency Query Responses to more than 36 different products (EMA, USFDA, TGA, WHO, MCC, etc.)

 

• Controlled Correspondence to USFDA on many occasions including:

 

• OGD Recommendations when BE recommendations not published (Tranylcypromine, Methanamine Hippurate, Chlorzoxazone);

 

• Inclusion of additional strength in a single ANDA application;

 

• when RLD is not present and consideration of RS product, Study Design and Statistical approach different from the recommendation, etc.

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• Successful development of IVIVC models and its application in product development.

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• Experience working with Reputed Biostat and Pharmacokinetic Scientist for statistical approaches and increasing the probability of success on products with High Variability, Atypical pharmacokinetic profiles, etc.

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• Dossier Compilation for 12 products.

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• DMF Preparation for 07 products.

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• Speaker and Presentation on International platforms.