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UNLOCKING INNOVATIVE, SOLUTIONS,

UNLOCKING INNOVATIVE SOLUTIONS,

FDA Compliance Made
Quick and Easy

"Empowering Your Business"

UNLOCKING INNOVATIVE, SOLUTIONS,

FDA Compliance Made
Quick and Easy

"Empowering Your Business"

Food

FSMA and Food Safety Food Labeling Prior Notice
  • FSMA and Food Safety
  • Food Labeling
  • Prior Notice

Medical Devices

UDI and GUDID
EMDR
Master Files

  • UDI and GUDID
  • EMDR
  • Master Files

Drugs

OTC Listings
Master Files
Drug Labeling

  • OTC Listings
  • Master Files
  • Drug Labeling

Cosmetics

Registration
Listings
Formulation Software

  • Registration
  • Listings
  • Formulation Software

Welcome to apcpharma

Delivering the Best Consulting Experience

We can also help you to perform the Analytical Studies, Validation, & Spectral Studies for Active Ingredients (APIs) and Formulations. Our Panel of Experts is having rich experience in setting up systems like GMP as per WHO / USFDA / MHRA / MCC/PMDA/MHLW / ICH guidelines as well GCP / GLP compliance as per ICH Guidelines.
  • Equipment Qualification
  • Vendor Qualification
  • Facility Qualification
  • Partnerships
15 Years of Consulting Experience
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what we’re doing

Services

We help the firms in designing their documentation system to meet international standards of US FDA, WHO, EU, PICS, TGA, ICH Q7, MHRA, PMDA,EDQM.MCC. The documents shall include QMS, Batch documentation, Validation, Recording forms and formats and SOPs and all relevant /associated GMP documentation.

AUDIT AND GAP ANALYSIS

GAP Analysis ( For WHO, USFDA, EU-GMP, EDQM, KFDA, MHRA, Schedule-M, State GMP, Health Canada, TGA, MCC, South Africa, PMDA.
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QC/QA/RA RELATED ACTIVITY

Preparation of Master Batch Record, SOP’s,Monthly report, Production planning,vessel- Utilization report,Raw material planning.
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Regulatory Affairs

Regulatory filings of Generics ANDA/ANDS etc. to US, Europe, Canada, Japan, ASEAN Countries and Row market Technical Data Package Development.
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Plant designing & commissioning

We provide services for designing
& commissioning of old a…

Third party GMP
Audits

We conduct third party GMP compliance audits of following …

Quality Management System

We provide technical guidance to design, prepare and imple…

Pre-Inspection
Audits

We provide guidance and conduct GAP analysis audit before …

TECHNOLOGY TRANSFER
ACTIVITY

Technical Discussion with R & D team for the scale up of new products. Selection of suitable equipments as per the process suitability.
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TRAINING PROGRAME FOR
WORK MEN & STAFF

GMP awareness ,GLP awareness, WHO GMP awareness WHO-GMP certificate audit preparation QMS awareness ,TQM awareness Validation Utility services
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Equipment Handling With Trouble Shooting

Knowledge to Operate different process equipment like all type of Reactor, Tray Dryer, Vacuum Tray Dryer, Nutsche Filter, Sparkler Filter, Micron filter,
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Qualifications & Validations

We provide guidance & prepare Qualification &a…
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Regulatory
Affairs

We provide regulatory services to Active Pharmaceu…
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Custom
Synthesis

We provide custom synthesis
services through our n…
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Formulation
Development

We provide services in following formulation devel…
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Why APCPharma Solution?

  • Meeting set targets within stipulated timelines
  • Compliance with Global Quality Standards
  • Proven Past Track Record
  • Commitment to Quality and Timely deliverance
  • Interacting with the personnel on shop floor to resolve issues
  • Qualified and Competitive team
  • Professional Excellence
  • Quality at a Reasonable cost
  • Ready to face audits by worldwide Regulatory authorities
  • Conducting audits for European/ Japanese customers in accordance with EDQM/EMEA/PMDA requirements

Where do we fit?

We understand user’s needs and serve satisfaction to our clients.We act as an employee and help our clients in preparation. implementation and monitoring of QMS as per national and international cGMP guidelines.
We conduct GAP analysis and help our clients in Plant Designing/ Re-designing, & Commissioning, Qualifications & Validations of Utilities and Equipment as per national and international cGMP guidelines.
We have a team of Subject Matter Experts in diversified areas of Pharmaceutical Formulations, APIs, Medical Devices and Food Products manufacturing industries.

our feedback

Clients are

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On the other hand denounc with ghteo indignation and dislike men who so beguiled and demoralized the charms.
On the other hand denounc with ghteo indignation and dislike men who so beguiled and demoralized the charms.
On the other hand denounc with ghteo indignation and dislike men who so beguiled and demoralized the charms.

Mike Hardson

Happy Client

Sarah Albert

Happy Client

Aleesha Brown

Happy Client

our feedback

Clients are

Talking

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Mike Hardson
Happy Client

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7 Days Ago
Tom Jones
Tesla CMO

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10.04.2018
Mark Wilson
Apple Manager

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5 Month Ago

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Consultancy Funfacts

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Leverage agile frameworks to provide a robust synopsis for high level overviews. Iterative approaches to corporate strategy data foster to collaborative thinking.
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