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

Medical Devices

UDI and GUDID
EMDR
Master Files

Drugs

OTC Listings
Master Files
Drug Labeling

Cosmetics

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.
15 Years of Consulting Experience

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.

QC/QA/RA RELATED ACTIVITY

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

Regulatory Affairs

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

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.

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

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,

Qualifications & Validations

We provide guidance & prepare Qualification &a…

Regulatory
Affairs

We provide regulatory services to Active Pharmaceu…

Custom
Synthesis

We provide custom synthesis
services through our n…

Formulation
Development

We provide services in following formulation devel…

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.

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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.

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our feedback

Clients are

Talking

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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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Iterative approaches tocorporate strategy data

No Comments

It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout. The point of using Lorem Ipsum is that it has a more-or-less normal distribution of letters, as opposed to using ‘Content here, content here’, making it look like readable English. Many desktop publishing packages and web page editors now use Lorem Ipsum as their default model text, and a search for ‘lorem ipsum’ will uncover many web sites still in their infancy. Various versions have evolved over the years, sometimes by accident, sometimes on purpose (injected humour and the like). There are many variations of passages of Lorem Ipsum available, but the majority have suffered alteration in some form, by injected humour, or randomised words which don’t look even slightly believable. If you are going to use a passage of Lorem Ipsum, you need to be sure there isn’t anything embarrassing hidden in the middle of text. All the Lorem Ipsum generators on the Internet tend to repeat predefined chunks as necessary, making this the first true generator on the Internet. It uses a dictionary of over 200 Latin words, combined with a handful of model sentence structures, to generate Lorem Ipsum which looks reasonable. The generated Lorem Ipsum is therefore always free from repetition, injected humour, or non-characteristic words etc.

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It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout. The point of using Lorem Ipsum is that it has a more-or-less normal distribution of letters, as opposed to using ‘Content here, content here’, making it look like readable English. Many desktop publishing packages and web page editors now use Lorem Ipsum as their default model text, and a search for ‘lorem ipsum’ will uncover many web sites still in their infancy. Various versions have evolved over the years, sometimes by accident, sometimes on purpose (injected humour and the like). There are many variations of passages of Lorem Ipsum available, but the majority have suffered alteration in some form, by injected humour, or randomised words which don’t look even slightly believable. If you are going to use a passage of Lorem Ipsum, you need to be sure there isn’t anything embarrassing hidden in the middle of text. All the Lorem Ipsum generators on the Internet tend to repeat predefined chunks as necessary, making this the first true generator on the Internet. It uses a dictionary of over 200 Latin words, combined with a handful of model sentence structures, to generate Lorem Ipsum which looks reasonable. The generated Lorem Ipsum is therefore always free from repetition, injected humour, or non-characteristic words etc.

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