Exclusive Services

EXPERTISE, EXPERIENCE & SERVICES

Experts at mKnal Global Solutions perform an In-depth assessment of product for appropriate decision making with understanding of product’s technical, scientific and regulatory requirements.

Our extensive experience in regulatory markets with a strong acumen on individual domain of product development has helped biopharmaceutical companies achieve success with a proven track record.

mKnal’s unique fusion of scientific, regulatory, global network of experts and partner has been able to successfully deliver quality objectives.

Expertise & Experience

FORMULATION & ANALYTICAL

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

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

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

CLINICAL DEVELOPMENT

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).

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.

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

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

CLINICAL MONITORING & AUDITING

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).

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

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

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

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

QUALITY ASSURANCE

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.

MEDICAL & SCIENTIFIC WRITING

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.

REGULATORY

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

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.

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

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.

Dossier Compilation for 12 products.

DMF Preparation for 07 products.

Speaker and Presentation on International platforms.